Arrow Recalls EVOLUTION Pressure Injectable PICC Catheters Due to Hub Tab Detachment
Arrow International is recalling EVOLUTION Pressure Injectable PICC catheters because the peel-away component hub tabs may prematurely detach during use.
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 with a mechanical defect that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling additional lots of the Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology. This action is part of an active recall to address a specific manufacturing defect.
The recall is due to the possibility that the catheter peel-away component hub tabs may prematurely detach when a practitioner begins to peel apart the sheath body from the catheter. This defect could occur during the insertion or setup process of the medical device.
The recall affects 9,037 units in the United States and 4,500 units internationally. The affected products were distributed to South Carolina, Alabama, New Jersey, Indiana, Massachusetts, Georgia, California, Pennsylvania, Arizona, Virginia, Washington, and Bangkok. The specific device listing number is D149129, with material numbers ASK-45552-RWJ4 and PR-45552-HPHNL. Healthcare providers should stop using the affected lots and contact Arrow International for further instructions.
The recalled product
- Product
- Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
- 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)
- Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL
Distribution
Part of a larger recall action
This product is one of 2 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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