The Recall Desk
HighFDA (Devices)·Z-0663-2019·Announced 2019-01-02

ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential for leakage in a medical device. No injuries or illnesses have been reported, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 25,640 units of the Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. The recall is due to a defect in the thermoset check valve component, which creates a potential for leakage.

The affected product is identified by item number 41424-03. The recall covers specific lot numbers with expiration dates ranging from December 1, 2020, to April 1, 2021. The product was distributed in 31 states and the District of Columbia, including Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.

Consumers and healthcare facilities should stop using the affected units and contact ICU Medical, Inc. for instructions on how to return or dispose of the product.

The recalled product

Product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Injectate Delivery System
Hazard
Affected units
25,640

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 3580037 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580037) 12/1/2020
  • 3580038 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580038) 12/1/2020
  • 3585768 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585768) 12/1/2020
  • 3585769 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585769) 12/1/2020
  • 3585770 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585770) 12/1/2020
  • 3585771 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585771) 12/1/2020
  • 3585772 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585772) 12/1/2020
  • 3585773 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585773) 1/1/2021
  • 3585774 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585774) 1/1/2021
  • 3585775 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585775) 1/1/2021
  • 3598139 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598139) 1/1/2021
  • 3598143 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598143) 1/1/2021
  • 3610803 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3610803) 1/1/2021
  • 3642242 ((01) 0 0840619 04414 5 (17) 210301(30) 01 (10)3642242) 3/1/2021
  • 3656680 ((01) 0 0840619 04414 5 (17) 210401(30) 01 (10)3656680) 4/1/2021

Distribution

Distributed in 31 states:

Part of a larger recall action

This product is one of 3 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage

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