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.
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: 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
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