FDA-Device2017-07-19Class II
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Arrow International Inc
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.
Sold states
Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Affected count
9,037 units in the U.S. and 4,505 Internationally
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2699-2017Don't want to check this manually?
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