Arrow International Recalls Multi-Lumen Hemodialysis Catheterization Kits Due to Sterility Concerns
Arrow International is recalling specific lots of Multi-Lumen Hemodialysis Catheterization Kits because the seals may be incomplete, preventing a guarantee of product 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 sterility cannot be guaranteed, posing a risk of infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling certain lots of Multi-Lumen Hemodialysis Catheterization Kits for High Volume Infusions, Part Number CDC-12123-P1A. The recall is being conducted because the cardiovascular catheters may not be completely sealed, which means the sterility of the product cannot be guaranteed.
The affected product was distributed in all 50 U.S. states and the District of Columbia, as well as in the Bahamas, Canada, Mexico, Panama, and Singapore. The specific lot number involved in this recall is 13F17F0081.
Consumers and healthcare facilities should check their inventory for this specific part number and lot number. If the product is found, it should be removed from use and returned to the supplier or the manufacturer in accordance with their instructions.
The recalled product
- Product
- Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
- 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 (1)
- Lot Number: 13F17F0081
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.
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