Recall Z-1100-2026 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
ICU Medical Inc.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
| Date | Jan 15, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On December 19. 2025, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that affected lots may have a crack present on the syringe collar. Customers were instructed to discontinue use of affected lots, and to destroy products following their institution's process for destruction. If destruction is not immediately possible, affected product should be quarantined until disposal. |
| Quantity | 64290 total |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952516 | PRO-VENT, LINE DRAW, PULSATOR Smiths Industries Medical Systems, Inc., Jul 14, 1995 |