Z-2699-2017 Class II Terminated
FDA device recall Z-2699-2017 was initiated by Arrow International Inc on June 12, 2017 and is designated Class II. Reason for recall: 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 p… The recall status is terminated (terminated September 6, 2018). Affected quantity: 9,037 units in the U.S. and 4,505 Internationally.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- June 12, 2017
- Termination Date
- September 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,037 units in the U.S. and 4,505 Internationally
Product Description
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Reason for Recall
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.
Distribution Pattern
Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Code Information
Device Listing # D184260 Material # PL-01055