Arrow Glide Thru Peel-Away Sheath Recall for Premature Hub Tab Detachment
Arrow International is recalling Glide Thru Peel-Away Sheath/Dilator Introducers because hub tabs may detach prematurely during use.
What this means for you
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 functional defect that could compromise the procedure, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling additional lots of the Arrow Glide Thru Peel-Away Sheath/Dilator Introducer. This action is part of an active recall. The product is a medical device used in catheter procedures.
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. The source text does not report any specific injuries or illnesses associated with this defect.
Approximately 9,037 units were distributed in the U.S. and 4,505 units internationally. U.S. distribution included South Carolina, Alabama, New Jersey, Indiana, Massachusetts, Georgia, California, Pennsylvania, Arizona, Virginia, and Washington. International distribution included Bangkok. The affected product is identified by Device Listing # D184260 and Material # PL-01055.
The recalled product
- Product
- Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- Manufacturer
- Arrow International Inc
- Hazard
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 # D184260 Material # PL-01055
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.
See all 2 products in this recall →Related recalls
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Same hazard · premature detachment
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- SevereArrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
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