Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
FDA device recall Z-1100-2026 · posted 2026-01-15 · Open, Classified
Recall details
- Recalling firm
- ICU Medical Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JKA
- Quantity affected
- 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.
- Date initiated
- 2025-12-19
- Date posted
- 2026-01-15
- Location
- Minneapolis, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRO-VENT, LINE DRAW, PULSATOR (K952516) | Smiths Industries Medical Systems, Inc. | 1995-07-14 |