Z-1100-2026Class II

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

Name: Z-1100-2026 Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Creator: ICU Medical Inc.
Published: 2025-12-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-12-19 / Open, Classified

FDA source

ICU Medical Inc. began a recall of Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG on 2025-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1100-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-01-15
Recalling firm: Abbott Medical
Product: Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-15
Z-1101-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-15

Product code JKA

K952516Class IIPro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. / cleared 1995-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)