Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Reported: July 19, 2017 Initiated: June 12, 2017 #Z-2699-2017
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.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 9,037 units in the U.S. and 4,505 Internationally
- Distribution
- Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer. Recalled by Arrow International Inc. Units affected: 9,037 units in the U.S. and 4,505 Internationally.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2699-2017.
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