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Arrow International Inc recalls Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Recalled July 19, 2017 · FDA recall Z-2699-2017 · Arrow International
Hazard
Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. · FDA Class II
Units
9,037 units in the U.S. and 4,505 Internationally
Sold at
Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Description
Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
Product
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →