Arrow International Recalls Certain Lots of ARROWg+ard Blue CVC Kits
Arrow International is recalling specific lots of ARROWg+ard Blue Central Venous Catheter (CVC) kits 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 is classified as FDA Class II. The hazard involves a potential sterility failure in a medical device, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Arrow International Inc is recalling specific lots of ARROWg+ard Blue Central Venous Catheter (CVC) kits and related catheterization kits. The recall includes five specific product configurations, including the ARROWg+ard Blue CVC Kit, Large-Bore Multi-Lumen CVC Kit, Central Venous Catheterization Kit with Blue FlexTip Catheter, and Hemodialysis Catheterization Kit for High Volume Infusions.
The recall was initiated because certain lots of these cardiovascular catheters may not be completely sealed. As a result, 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.
Healthcare facilities and consumers should check their inventory for the specific part numbers and lot numbers listed in the official recall notice. If the products match the recalled lots, they should be removed from use and returned to Arrow International Inc according to the firm's instructions.
The recalled product
- Product
- ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
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 (17)
- Lot Numbers: (1) 13F17B0345
- 13F17E0644
- 13F17E0871
- 13F17F0291
- (2) 13F17B0124
- 13F17B0355
- 13F17E0727
- (3) 13F16M0266
- 13F17C0484
- 13F17E0798
- (4) 13F17B0037
- 13F17E0451
- (5) 13F17A0017
- 13F17A0314
- 13F17D0060
- 13F17E0799
- 13F17F0489
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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