GAWDA



GAWDA Medical Gas Alert Teleconference

February 5, 2015 at 3:00 PM EST

Western/Scott Fetzer voluntary recall for OxyTOTE/oxyQuik/AirTOTE products, including OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG, AirTOTE, and oxyQuik Series Valve Integrated Pressure Regulators, and all private label versions of these products.

Voluntary Recall Notice sent January 31, 2015

Agenda

• GAWDA Meeting Guidelines are in place

• Review of the handouts

• Review of sample recall procedures you can adopt/revise to fit your situation

• Background

• How to decide if this recall affects you

• Remediation schedule

• Resolution and actions required for this voluntary recall

• Q&A

|Purpose |Describe an example of a procedure for implementing and communicating effective product recall requirements in accordance with|

| |regulations. |

| | |

|Scope |Applicable to facilities considering, or are involved in a recall. |

| | |

|Definitions |Product Recall |A company’s removal or correction of a regulated product, which is considered to be in violation of|

| | |FDA regulations, and for which the Agency might initiate legal action (i.e. Seizure). |

| |Market Withdrawal |A company’s removal or correction of a distributed product which involves a minor deviation that |

| | |would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock |

| | |rotation practices, routine equipment adjustments and repairs, etc. |

| |Stock Recovery |A company’s removal or correction of a product that has not been marketed or that has not left the |

| | |direct control of the firm, i.e., the product is located on premises owned by or under the control |

| | |of the firm and no portion of the lot has been released for sale or use. |

| |Violative Product |A product in violation of cGMP requirements or other FDA regulations |

| |Supplier |The provider of drug or device implicated. |

| | |

|Attachments |Title |

| |Recall Record Form |

| |Recall Customer Work List Form |

| |Recall Action Plan |

Recall policy

Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. Recall is an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products by setting forth specific recall procedures for the Food and Drug Administration to monitor recalls and assess the adequacy of a firm's efforts in recall.

Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration that a firm recall a product is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled.

Product Recall Strategy

A planned specific course of action to be taken in conducting a specific product recall, which addresses the depth of product recall, communications, execution, and the extent of effectiveness checks for the product recall.

A recall strategy that takes into account the following factors will be developed by the recalling firm for a firm-initiated recall to suit the individual circumstances of the particular recall:

• Results of health hazard evaluation.

• Ease in identifying the product.

• Degree to which the product's deficiency is obvious to the consumer or user.

• Degree to which the product remains unused in the market-place.

• Continued availability of essential products.

The Food and Drug Administration will review the adequacy of a proposed recall strategy developed by a recalling firm and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy.

Product Recall Classification

The numerical designation assigned by the FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

1. Class I or 1 - A situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

2. Class II or 2 - A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

3. Class III or 3 - A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Depth of Recall

Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows:

3 Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or

4 Retail level, including any intermediate wholesale level; or

5 Wholesale level.

Effectiveness Checks

Verification of investigations by direct visits, telephone calls, letters or other verified methods in order to assure that consignees have been notified of the recall based on the recall depth specified by the strategy, have received notification and have taken appropriate action. The Effectiveness Check Level is an alphabetic term representing the depth of consignee contact.

Level A - 100 % of the total number of consignees to be contacted.

Level B - A percentage of the total number of consignees to be contacted. The percentage is to be determined on a case-by-case basis, but shall be greater than 10 % and less than 100 % of the total number of consignees.

Level C - 10 % of the total number of consignees shall be contacted.

Initial Notification

As the Complaints procedure is followed, if it involves death, injury, hospitalization or an otherwise adverse reaction in which it is alleged that the company’s product is implicated, the company’s QCU representative and top management will be notified immediately. An FDA Form 3500A will also be submitted.

The QCU representative will ascertain all available facts and consult with appropriate parties to determine whether the problem actually fits within the scope of this procedure.

Should the problem not fit within the scope of this procedure, the QCU representative will document and communicate this determination to the company’s appropriate management. Should the problem fit within the scope of this procedure, the QCU representative will document and communicate it to the company’s top management.

The QCU representative will notify and call an immediate meeting with appropriate management representatives of Operations, Technical, Sales, Marketing and Legal Counsel. This group shall form the Recall Action Committee (RAC); the QCU representative or designee from QCU will be its’ chair. Others may be requested to attend by the QCU representative.

The RAC will review all available information. A decision will be made as quickly as possible to decide one of the following.

No action is required.

Possibility of product recall exists - more data required.

Product recall is indicated.

Any of the decisions and reasoning in step 5 will be documented. If no action is required, the rationale and data to support that decision will be a part of the documentation. If more data is required, its need will be documented. Also, clear ownership of what is required, who is responsible for securing that data, when it will be available, and what actions will be taken once the data is available. If product recall is indicated, documentation will indicate the rationale for the decision, including appropriate data and records as per Recall Record and Customer List Worksheet in attachments to this procedure. Documentation will also include the agreed-to product recall strategy.

The decision will be made as a recommendation to the company’s top management for their review and approval. If not approved, the RAC will reconvene to address the reasons and propose changes.

If a product recall is deemed necessary, the consignees/customers who received the product shall be identified, and must be notified immediately. This should be supplemented by a written communication from the originating party describing the recall situation.

Firm internally-initiated Recall Execution

The QCU representative will contact the FDA district office with a notification of the intended product recall action. The FDA will require the following information:

2 Identity of the product involved & the reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered.

3 Evaluation of the risk associated with the deficiency or possible deficiency.

4 Total amount of such products produced and/or the time span of the production in question.

5 Total amount of such products estimated to be in distribution channels.

6 Distribution information, including the number of direct and other accounts and, where necessary, the identity of the accounts.

7 A copy of the company’s product recall communication if any has been issued, or a proposed communication if none has been issued.

8 Proposed strategy for conducting the product recall including depth of product recall and proposed communication methods.

9 Name and telephone number of the official from the company who should be contacted concerning the product recall.

FDA will review adequacy of the proposed product recall strategy and may agree or recommend changes as appropriate.

QCU representative or designee will act as a Product Recall Coordinator to oversee and coordinate the entire product recall procedure.

The QCU representative will insure the approved product recall strategy is executed and issue periodic update reports as appropriate.

Supplier externally-initiated Recall Execution

The company will receive notification of the intended product recall action from the supplier. The supplier would have already consulted with the FDA about the recall details. The FDA publishes recall information on their website.

QCU representative or designee will act as a Product Recall Coordinator to oversee and coordinate the entire product recall procedure.

The QCU representative will insure the approved product recall strategy is executed and issue periodic update reports as appropriate.

Communications

General - The types of communication used to affect the product recall will depend upon the degree of product hazard and extent of distribution. If this product presents serious health hazard, it may be necessary to issue public warnings. Should this be the case, warnings and plans for distribution of the warning should be submitted to FDA for comment. All communications should be cleared through Legal Counsel prior to transmission. Products recall strategy shall specify whether a public warning is needed.

The purpose of a product recall communication is to convey:

That the product in question is subject to a recall.

• That further distribution or use of any remaining product should cease.

• Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.

• Instruction regarding what to do with the product.

Implementation. A recall communication can be accomplished in writing conspicuously marked, preferably in bold red type, on the letter and the envelope: “DRUG RECALL” or “DEVICE RECALL”, as appropriate . The letter and the envelope should be also marked: "URGENT" as per the FDA assigned Classification. Telephone calls or other personal contacts should ordinarily be confirmed in writing and documented in an appropriate manner.

Product Recall communications contents should be in accordance with the following guideline

Be brief and to the point.

Product, size, lot number(s), code(s) and any other pertinent descriptive information shall be clearly identified for accurate and immediate identification of the product.

The reason for the product recall and the hazard involved, shall be explained.

Specific instructions on how the recalled products should be handled.

A ready means for the recipient of the communication to report to the company whether it has any of the product. The QCU representative will designate a person for receipt of these returned communications. This contact shall tabulate return communications in accordance with the product recall strategy.

Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication.

Return of Recalled Product

If the Recall Strategy determines that the product needs to be returned, the QA Coordinator will determine a “positive check” method for such returns. As material is returned, the required information will be forwarded to the QCU representative for future communication to FDA or Supplier Company for effectiveness of recall.

Product Recall Status Reports

The QCU representative shall submit periodic product recall status reports to the appropriate FDA District Office so that the Agency may assess the progress of the product recall. In the case of Supplier Initiated Recall, the supplier may request status report(s) so the supplier can make the submission to the FDA in lieu of the company reporting to the FDA. The frequency of such reports will be determined by the relative urgency of the product recall and shall be specified by the FDA in each product recall case. Generally the reporting interval is 2-4 weeks.

The Recall Status Reports should contain the following information:

Number of customers notified of the product recall, and date and method of notification.

Number of customers responding to the product recall communication and quantity of products on hand at the time it was received.

Number of customers that did not respond (if needed, the identity of non- responding customers may be requested by the FDA).

Number of products returned or corrected by each customer contacted and the quantity of products accounted for.

Number and results of effectiveness checks that were made.

Estimated time frames for completion of the product recall.

Supplier-Initiated Recall Status Report contents will be determined by the supplier and may be different than the list above.

Termination of a Product Recall

In the case of firm internally-initiated recalls:

2 The QCU representative will request termination of product recall by submitting a written request to the appropriate FDA District Office. The written request will state that the product recall is effective in accordance with the criteria set forth in the FDA Product recall guidelines.

3 A product recall will be terminated when the FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the product recall strategy.

4 This will be when it is reasonable to assume that the affected product has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.

5 The appropriate FDA district Office will issue written notification that a product recall is terminated to the recalling firm.

In the case of Supplier externally-initiated recalls:

7 The QCU representative will determine that the product recall is terminated by consulting the recall request from the supplier.

8 This will be when it is reasonable to assume that the affected product has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.

Records Retention - All records of Product Recall will be maintained ten years from the date of the initiation.

Recalled Product Disposition

The QCU representative will recommend the proper disposition of recalled product. The decision must be agreed to by the Recall Action Committee and the FDA. Supplier Initiated Recalls will be guided by the supplier’s recall notice regarding disposition of the product.

All violative products will be destroyed only after consultation with FDA and/or based on provided notification.

Recall Closure

The QCU representative or designee shall prepare a final report including the following information:

All available evidence concerning the problem.

Analytical, pharmacological and/or bacteriological data pertinent to the product concerned.

Production and inventory records.

Decision of the Recall Action Committee and the rationale for same.

All records necessary for possible claims against outside parties.

A summation of the effectiveness of the product recall.

Corrective / Preventative Action to prevent recurrence in the future.

The report will be distributed to the members of the Action Committee and the company’s appropriate management.

Guidance for Entering Information onto Recall Record Form

The responsible individual shall:

Enter a Recall reference number YYYY-NN (e.g., 2014-01) at the top of the form.

The responsible individual shall determine product types and record the lots/part number/model of affected scope of product.

NOTE: The QCU representative shall assist in this step. For gas and liquids, check previous and subsequent lots to determine if residuals from such lots could be implicated. If implicated, trace the supply gas lots to other mixtures, which might contain the same supply. Report those lots and the relationships to the QCU representative.

The responsible individual shall check current inventory of any product used for "in-house" purposes that may be part of the same group as those recorded in space(s) B above. A qualified person (appointed by the responsible individual) shall quarantine any products found and record, as appropriate, the lot numbers, product part numbers, or model numbers and as applicable, the amount of cylinders by cylinder size. This information represents products, which the facility did not distribute. Use the spaces provided as needed.

NOTE: The QCU representative shall approve the release from quarantine, of all products related to a recall found in stock recovered, or returned in the normal course of business. Upon release from quarantine the products shall not be processed until the QCU representative provides directives regarding disposition.

Check Records for amounts of each product recorded above. The responsible individual shall determine and record the amount of product the facility distributed.

As each form page is completed, sign and date the Recall Record.

The responsible individual shall interrelate and attach all corresponding paperwork. They shall also number the pages as appropriate.

Entering Information on to Customer Work List Form

The responsible individual shall:

Use Lot Distribution Records and shipping orders, or Medical Customer List and/or alphabetical file to complete a Customer List Worksheet of customers who received the product of the lot/part/model.

Record the customer names, Shipper / Invoice / lot / part / model numbers as useful, and cylinder sizes/amount the customer received.

NOTE: The responsible individual shall attach copies of all Fill Logs, Lot Distribution Records, and Shipping Orders, or whatever is applicable to the Recall Record & Customer Work List Forms.

Assign a qualified person(s) to contact by telephone each customer, deliver a recall communication, and make arrangements to pickup implicated cylinders. The qualified person shall contact the purchasing agent if an institution, the doctor if a private office, or the manager if a distributor. As the qualified person contacts each customer, he/she shall document the name of the individual and date of contact.

Make arrangements with appropriate individuals to pick up the product as soon as possible.

Quarantine all recovered products (account for by customer on the Customer List Worksheet) in recall. Indicate Amount Recovered and the date of recovery. The assigned person shall mark each recovered item (e.g., tags, tape, etc.) to indicate the customer name.

The facility shall send an official letter of recall, ("registered mail return receipt requested"), if the assigned person cannot completely recover the products by telephone correspondence. As the assigned person mails each letter, they shall record the registered mail receipt number.

Record "receipt returned", upon delivery of the return receipt.

Check all products returned in the normal course of business for recall status. If the assigned person finds any implicated product they must quarantine the product and record this activity on the Customer List Worksheet. They shall also indicate when, who from, and how the cylinders were recovered by recording the information, or by recording "see attached" and using an attached sheet of paper.

The QCU representative shall evaluate the effectiveness of the recall and determine whether the recall is complete or to be continued.

Upon completion of the recall, the QCU representative shall prepare a final report indicating the completion of the recall.

The responsible assigned individual shall interrelate and attach all corresponding paperwork. They shall also number the pages as appropriate.

RECALL RECORD FORM

For

Recall #

_________________

|Lot Numbers or Part/Model Number Selected For Recall |

| | | | |

| | | | |

|Products Not Distributed (Still In-House) |

|Lot/Part/Model # |

|Lot/Part/Model # |Type |Size |Quan |Type |Size |

|Identify the name of the QCU representative (Product |QCU |Name: | | | |

|Recall Coordinator) responsible for assuring the recall | | | | | |

|procedures are followed: | | | | | |

|Identify the Recall Classification |QCU representative |Class I - A situation in which there is reasonable probability that | | | |

|(Class I, Class II or Class III) based on the FDA | |the use of or exposure to a violative product will cause serious | | | |

|designation or the anticipated Class, pending designation.| |adverse health consequences or death. | | | |

| | |Class II - A situation in which use of or exposure to a violative | | | |

| | |product may cause temporary or medically reversible adverse health | | | |

| | |consequences or where the probability of serious adverse health | | | |

| | |consequences is remote. | | | |

| | |Class III - A situation in which use of or exposure to a violative | | | |

| | |product is not likely to cause adverse health consequences. | | | |

|Identify the depth of the recall |QCU representative |Consumer or user level, which may vary with product, including any | | | |

| | |intermediate wholesale or retail level | | | |

| | |Retail level, including any intermediate wholesale level | | | |

| | |Wholesale level | | | |

| | |Other: | | | |

|Identify the effectiveness check level |QCU representative |Level A - 100 % of the total number of consignees to be contacted. | | | |

| | |Level B - A percentage of the total number of consignees to be | | | |

| | |contacted. The percentage is to be determined on a case-by-case | | | |

| | |basis, but shall be greater than 10 % and less than 100 % of the | | | |

| | |total number of consignees. | | | |

| | |Level C - 10 % of the total number of consignees shall be contacted. | | | |

| | |Other: | | | |

|Does this recall involve a complaint in our files? |QCU representative |Yes – List the complaint date or ID: | | | |

| | | | | | |

| | |No – List the reason/cause for the recall: | | | |

|Has Top Management been notified? |QCU representative |Yes – List the name(s) and dates of notification: | | | |

| | | | | | |

| | | | | | |

| | |No – List the reason Top Management was not notified: | | | |

|When was the FDA Form 3500A submitted? (If not applicable:|QCU representative | | | | |

|N/A) | |Submitter’s name:________________________ |N/A |N/A |N/A |

| | | | | | |

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|Does this recall fall within the scope of our recall |QCU representative |Yes | | | |

|procedure? | |No – List the reason this recall does not fall within the scope of | | | |

| | |this procedure and alternate procedures to be used. Also list Top | | | |

| | |Management who were notified that this procedure does not apply: | | | |

| | | | | | |

| | | | | | |

| | | | | | |

|The Recall Action Committee (RAC) is formed. List the |QCU representative | | | | |

|names of the RAC management representatives: | |Chair, QCU rep.: | | | |

|(The same person may fill several roles.) | |Operations Mgmt.: | | | |

| | |Technical Mgmt.: | | | |

| | |Sales Mgmt.: | | | |

| | |Marketing Mgmt.: | | | |

| | |Legal Counsel: | | | |

| | |Other: | | | |

|The RAC meets as soon as possible and decides the type of |QCU representative | | | | |

|action required. | |Meeting date: | | | |

| | |Action required: | | | |

| | |No action is required. | | | |

| | |Possibility of product recall exists - more data required. | | | |

| | |Product recall is indicated. | | | |

| | |Other action: | | | |

|The RAC documents the rationale for the action/no action |RAC |Rationale and data to support the decision. If recall is decided, | | | |

|decision above: | |attach Recall Record and Customer List Worksheet: | | | |

| | | | | | |

| | | | | | |

| | | | | | |

| | | | | | |

| | | | | | |

| | |If more data is required, what is needed? Who will secure the | | | |

| | |additional data? What action will then be taken? | | | |

| | | | | | |

| | |Attach as needed. | | | |

|Top management reviews and approves or disapproves the |RAC |Who in Top Management reviewed the recommended action? | | | |

|recommended action above. If not approved, the RAC will | |________________________ Date: __________ | | | |

|reconvene to address the reasons and propose changes. | | | | | |

| | |Was the recommended action: | | | |

| | |Approved | | | |

| | |Not approved | | | |

| | |Other: | | | |

| | | | | | |

| | |Approver name:_____________________ | | | |

| | | | | | |

| | |Approval Date: _________ | | | |

|What “positive check” or other method was employed to |QCU representative |Describe checks and follow-up: | | | |

|ensure the action was effective? | | | | | |

| | | | | | |

| | | | | | |

|The date consignees/customers who received the product |RAC |Date: | | | |

|were identified: | | | | | |

|The date consignees/customers who received the product |RAC |Date: | | | |

|were notified about the recall: | | | | | |

|How were the consignees/customers notified: |RAC |Notification method: | | | |

| | | | | | |

|(Attach written communication) | | | | | |

| | | | | | |

|What periodic reports/updates were sent to the FDA? In the|RAC | | | | |

|case that a supplier initiated the recall, what periodic | |What Report? Date: | | | |

|reports/updates were sent to the supplier? | | | | | |

| | |What Report? Date: | | | |

|(Attach reports/updates as needed) | | | | | |

| | |What Report? Date: | | | |

| | | | | | |

| | |What Report? Date: | | | |

| | | | | | |

| | |What Report? Date: | | | |

|Date the recall is closed by the FDA or supplier: |RAC | | | | |

| | |Date:____________________ | | | |

| | | | | | |

| | |Recall Coordinator: ________________________ | | | |

|Notes: |

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Customer Work List Form

Page ______of ______

|Customer Name or Contact |Shipper Number / Invoice |Size / Amount on Record |Size / Amount Recovered |Date Recovered |Remarks |

| |Lot Number or other info. | | | | |

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