Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Reported: January 21, 2026 Initiated: December 19, 2025 #Z-1100-2026
Product Description
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
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.
Details
- Recalling Firm
- ICU Medical Inc.
- Units 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.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG. Recalled by ICU Medical Inc.. Units affected: 64290 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1100-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11