Arrow Endurance Extended Dwell Peripheral Catheter System Recalled for Sterility Concerns
Arrow International Inc is recalling specific lots of the Arrow Endurance Extended Dwell Peripheral Catheter System due to a potential sterility issue.
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 involves a potential sterility issue in a medical device, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc is recalling 575 units of the Arrow Endurance Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. The recall is due to a potential sterility issue affecting specific manufacturing lots.
The affected lots are 13F19E0247, 13F19F0006, and 13F19G0433, with expiration dates ranging from August 2020 to September 2020. These products were distributed in Florida.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 575
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 (3)
- REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247
- 13F19F0006
- and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020
Distribution
Distributed in 1 state:
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