Arrow International Recalls Hemodialysis Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling specific hemodialysis catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
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 medical device where compromised sterility poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Arrow International is recalling the ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions. The recall is being conducted because the packaging for these devices may not be completely sealed, which may compromise the sterility of the catheters.
The affected products are identified by material numbers CDA-22122-U1A, CDC-22141-1A, and CDC-26142-1A, under Device Listing D025726. The company distributed 27,485 units in the United States and 4,371 units internationally, with distribution patterns covering the U.S. (nationwide) and Canada.
Healthcare providers and consumers should check their inventory for the specific material numbers listed above. If the packaging is found to be compromised or unsealed, the devices should not be used. Users should contact Arrow International for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It…
- 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 (2)
- Material number: CDA-22122-U1A
- CDC-22141-1A CDC-26142-1A Device Listing D025726
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
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