Oscor Adelante Breezeway 10f C120¿ S61cm D66cm recall
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart…
Why was Oscor Adelante Breezeway 10f C120¿ S61cm D66cm recalled?
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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?
Lot #'s: C1-12145 Exp. November 29, 2018, C1-08466 Exp. December 19, 2016 and OR-04823 Exp. June 16, 2019
- Product
- OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart…
- Recalling firm
- Oscor, Inc.
- Quantity
- 8
- Distribution
- Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)