Arrow Recalls Single-Lumen Central Venous Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling single-lumen central venous 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arrow International is recalling the Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter. The recall is being conducted because the packaging for these devices may not be completely sealed. This defect may compromise the sterility of the catheters.
The affected product is a percutaneous catheter that permits venous access to the central circulation. The material number for the recalled items is Ask-04301-WBH, and the device listing number is D040650.
A total of 27,485 units were distributed in the United States and 4,371 units were distributed internationally. The distribution pattern includes nationwide distribution in the U.S. and Canada. Consumers and healthcare providers should check their inventory for this specific material number and stop using any units where the packaging seal is compromised.
The recalled product
- Product
- Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
- 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)
- Material number: Ask-04301-WBH Device Listing D040650
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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