Oscor Adelante Breezeway 8f C55¿ S61cm D66cm recall
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers…
Why was Oscor Adelante Breezeway 8f C55¿ 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: C1-09714 Exp. February 11, 2018, OR-04657 Exp. April 20, 2018, C1-10900 Exp. July 19, 2018, C1-10899 Exp. July 19, 2018, C1-11048 Exp. August 3, 2018, C1-11729 Exp. October 4, 2018, C1-11729 Exp. October 4, 2018, OR-04729 Exp. October 29, 2018, C1-12233 Exp. December 21, 2018, C1-12234 Exp. December 22, 2018, C1-12234 Exp. December 22, 2018, C1-09062 Exp. June 24, 2017, C1-09062 Exp. June 24, 2017, C1-11047 Exp. August 3, 2018 and C1-12234 Exp. December 22, 2018 2
- Product
- OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers…
- Recalling firm
- Oscor, Inc.
- Quantity
- 156
- 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)