Arrow International Recalls Two-Lumen PICC Kits Due to Sterility Concerns
Arrow International is recalling specific lots of two-lumen PICC kits because the catheters 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 sterility cannot be guaranteed, posing a risk of infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling certain lots of Arrow Pressure Injectable Two-Lumen PICC Kits, Product Number EU-05052-HPMSB. The recall is being conducted because the cardiovascular catheters in these kits may not be completely sealed, meaning the sterility of the product cannot be guaranteed.
The affected product, identified by Lot Number 13F17B0123, was distributed in all 50 U.S. states and the District of Columbia. It was also distributed in the Bahamas, Canada, Mexico, Panama, and Singapore.
Healthcare providers and consumers should stop using the affected lots and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
- 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: 13F17B0123
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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