URGENT: MEDICAL DEVICE RECALL

600 N. Field Drive Lake Forest, IL 60045



URGENT: MEDICAL DEVICE RECALL

IV Administration Sets with an Incorrect Drop Cannula in the Drip Chamber See Table 1 for Affected Item and Lot Numbers

04 October 2019

Dear Valued Customers: Director of Risk Management Director of Nursing Director of Biomedical Engineering

ICU Medical, Inc. is issuing this Urgent Medical Device Recall letter to notify you of an issue with certain lots of IV administration sets that may contain drip chambers with an incorrect drop cannula. This urgent medical device recall letter details the issue and the required steps for you to perform.

Issue: ICU Medical has identified finished good lots that may contain drip chambers with a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula.

Potential Risk: When using drop count to estimate flow rate during a gravity infusion, an infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). There is a remote possibility that underdelivery of critical medications may to lead to serious adverse health consequences. To date, ICU Medical has not received any reports of serious injury or death associated with this issue.

Affected Product: Our records indicate that you have received some of the affected products, which were distributed in United States between July 2019 and August 2019. The affected item and lot numbers are provided in Table 1.

Required Actions for Users:

1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.

2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product.

3) Return affected product using the return label provided with this letter. Contact Stericycle at 1-866-367-4703 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. You will only receive credit for product that you return. NOTE: Credits for product purchased through distributor will be credited by the distributor.

4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-866-367-4703 (M-F, 8am-5pm ET) to obtain a response form.

Follow up Actions by ICU Medical: Replacement product is available. Please contact Customer Service using the information provided below.

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Item No. AH7117 B90240-50 B9900-287 MC330424 Z2560

Z2812

Z2850 Z3239 Z3806

Table 1: Affected Product and Lot Numbers

Description

111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer

96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave?, Rotating Luer

82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set w/Pre-Slit Port, ClaveTM, 1 Ext, Rotating Luer

145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClaveTM Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClaveTM Clear

100" 10 Drop Admin Set w/Hand Pump, 2 ClaveTM, Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp

121" 10 Drop Primary Set w/5 MicroClaveTM, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext

112" (284 cm) 10 Drop Primary Set w/2 ClaveTM, Remv 3 Gang 1o2TM Manifold w/3 ClaveTM, Baseplate, Rotating Luer w/Filter Cap, 1 Ext

126" 10 Drop Primary Set w/3 MicroClaveTM, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext

131" (333 cm) 10 Drop Primary Set w/2 MicroClaveTM, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext

Lot Numbers

4173657 4168837 4169606 4168835 4167007

4168883

4172061 4173149 4168876 4168877 4169640 4169641 4172062

4169647

4169642

Expiration Date

All affected lots expire 01-July-2024

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