Arrow Arterial Kits Recalled Due to Open Packaging Seals
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves sterile medical devices used in invasive arterial procedures, where open seals pose a risk of contamination and potential infection. No injuries or illnesses have been reported, placing this in the 'risk-of-harm' category per the rubric.
Plain-English summary
Arrow International is recalling 14,845 arterial catheterization kits and trays across 15 different product models. The recalled products include Arrow Arterial Access Trays, Arrow Arterial Access Kits, Arrow Arterial Catheterization Kits, Arrow Arterial Line Kits, Arrow Radial Catheterization Kits, and Arrow QuickFlash Radial Artery Catheterization Kit.
The recall was initiated due to reports of open seals on the packaging. Open seals on sterile medical device packaging pose a risk of contamination and could compromise the sterile integrity of the kits.
The affected kits have been distributed nationwide to medical facilities in California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, North Carolina, New York, Pennsylvania, and West Virginia. Specific batch numbers and UDI codes have been identified for each product model.
Healthcare facilities that have received these products should immediately cease use, quarantine affected inventory based on the provided batch numbers and UDI codes, and contact Arrow International for replacement units or further guidance.
The recalled product
- Product
- Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- open-seal
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (1) REF ASK-04001-BW1: Batch numbers 33F23M0157
- 33F24C0002
- 33F24C0136
- and 33F23L0297
- UDI-DI: 10801902117585
- (2) REF ASK-04001-CK: Batch numbers 33F24A0390
- 33F24B0233
- 33F24A0260
- 33F24A0036
- and 33F23L0738
- UDI-DI: 00801902091215
- (3) REF ASK-04001-VAMC1: Batch numbers 33F24A0825 and 33F24B0235
- UDI-DI: 10801902158854
- (4) REF ASK-04020-BHS: Batch numbers 33F24C0678
- 33F23K0881
- 33F24B0788
- 33F24A1676
- 33F24A0711
- and 33F23L0687
- UDI-DI: 30801902144578
Distribution
Distributed nationwide across the United States.
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