Device product
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Z-2699-2017
Product summary
- Event
- Event 77604
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,037 units in the U.S. and 4,505 Internationally
- Official record key
device-enforcement:Z-2699-2017
Official wording
Reason: 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.
Code information: Device Listing # D184260 Material # PL-01055
Distribution pattern: Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Derived failure modes
-
Unknown
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.