Oscor Adelante Breezeway 10f C70¿ S79cm D84cm recall
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers…
Why was Oscor Adelante Breezeway 10f C70¿ S79cm D84cm 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: C1-08611 Exp. February 20, 2017, C1-09397 Exp. November 17, 2017, C1-09408 Exp. November 25, 2017, C1-09408 Exp. November 25, 2017, C1-09861 Exp. March 5, 2018, C1-09858 Exp. March 5, 2018, C1-09861 Exp. March 5, 2018, C1-10901 Exp. July 19, 2018, C1-11205 Exp. August 24, 2018, C1-11205 Exp. August 24, 2018, C1-12250 Exp. January 4, 2019, C1-08611 Exp. February 20, 2017, and C1-11205 Exp. August 24, 2018
- Product
- OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers…
- Recalling firm
- Oscor, Inc.
- Quantity
- 124
- 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)