Arrow International Recalls Certain Lots of Cardiovascular Catheters for Sterility Concerns
Arrow International Inc is recalling specific lots of cardiovascular catheters because the products may not be completely sealed, meaning sterility cannot be guaranteed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (medical device) where sterility cannot be guaranteed, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Arrow International Inc is recalling certain lots of cardiovascular catheters, including Access Trays, Arrow Multi-Lumen CVC Kits, and Arrow Two-Lumen CVC Kits. The recall is being conducted because the products may not be completely sealed, which means the sterility of the product cannot be guaranteed.
The affected products were distributed in all 50 U.S. states and the District of Columbia, as well as in the Bahamas, Canada, Mexico, Panama, and Singapore. Specific lot numbers are listed in the structured product information for the Access Tray and various CVC Kit part numbers.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
- Manufacturer
- Arrow International Inc
- Hazard
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 (15)
- Lot Numbers: (1) 13F17E0546
- (2) 13F16L0177
- 13F17E0449
- 13F17E0873
- 13F17F0295
- (3) 13F17E0677
- 13F17F0477
- (4) 13F17A0318
- 13F17F0083
- (5) 13F16M0272
- 13F17E0648
- (6) 13F17B0122
- 13F17F0512
- (7) 13F17A0320
- 13F17F0528
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 14 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
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- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
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- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
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Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
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- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
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- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
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Similar recalls
- ModerateArrow Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2017-06-21
- HighArrow International Recalls Multi-Lumen CVC Kits Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Two-Lumen Central Venous Access Kits
FDA (Devices) · 2017-06-21
- HighArrow International Recalls Central Venous Catheter Kits Due to Sterility Risk
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
FDA (Devices) · 2018-06-06