Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns
Arrow International is recalling specific lots of hemodialysis catheterization kits because they may not be completely sealed, potentially compromising sterility.
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 medical device where sterility cannot be guaranteed, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc. is recalling certain lots of ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kits for High Volume Infusions. The recall involves specific part numbers and lot numbers identified in the agency's structured data. The product was distributed in all 50 U.S. states, the District of Columbia, and several international locations including the Bahamas, Canada, Mexico, Panama, and Singapore.
The recall is being conducted because certain lots of the cardiovascular catheters may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
Healthcare facilities and distributors should stop using the affected lots immediately. Consumers and medical professionals should check their inventory against the specific part numbers and lot numbers listed in the official recall notice to identify affected units.
The recalled product
- Product
- ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
- 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 (9)
- Lot Numbers: (1) 13F16M0268
- 13F17C0395
- 13F17E0158
- 13F17E0536
- (2) 13F17A0254
- (3) 13F16M0233
- 13F17D0190
- (4) 13F17B0137
- 13F17D0225
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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