ICU Medical Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
1. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4. 4080PE UDI-DI 30351688039150 Lot 6131839 5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →