Reported Jan 2, 2019 · Terminated
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
- Lot codes and dates
- Item number41424-03
- Lot number (UDI) Expiration Date3580033 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580033) 12/1/2020; 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
- Amount recalled
- 25,640 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential for leakage due to defect in the thermoset check valve component.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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