Arrow Glide Thru Peel-Away Sheath/Dilator Introducer recall
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Why was Arrow Glide Thru Peel-Away Sheath/Dilator Introducer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Listing # D184260 Material # PL-01055
- Product
- Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- Recalling firm
- Arrow International Inc
- Quantity
- 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
- Recall date
- July 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)