FDA Medical Device Recalls (openFDA)
ICU Medical Inc.: Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Recall number
- Z-1100-2026
- Recalling firm
- ICU Medical Inc.
- Product
- Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Status
- Open, Classified
- Initiated
- 2025-12-19
- Posted
- 2026-01-15
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K952516"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28