Arrow Hemodialysis Catheterization Sets Recalled for Tunneling Sheath Cracking
Arrow International is recalling specific hemodialysis catheterization sets because the tunneling sheath can crack during placement, potentially delaying treatment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a mechanical defect causing treatment delays, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling the Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access. The recall involves 2,480 units distributed in the US and Canada. The affected products are indicated for use in attaining long-term vascular access for hemodialysis and apheresis.
The recall was initiated because the tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities and distributors should stop using the affected lots and contact Arrow International Inc for instructions on how to return or replace the products. Specific lot numbers are listed in the official recall documentation.
The recalled product
- Product
- The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, C
- Manufacturer
- Arrow International Inc
- Affected units
- 2,480
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 (20)
- Lot numbers: RF2095946
- RF2056557
- RF2058764
- RF2060829
- RF2084897
- RF2084162
- RF2071325
- RF2060831
- RF2083836
- RF2096027
- RF2107409
- RF2108329
- RF2119933
- RF2060836
- RF2060899
- RF2083837
- RF2084898
- RF2107410
- RF2108324
- RF2071317
Distribution
Distribution scope not specified by the agency.
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