Oscor Adelante Breezeway 10f C90¿ S79cm D84cm recall
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers…
Why was Oscor Adelante Breezeway 10f C90¿ 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: C1-09848 Exp. March 4, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, C1-09099 Exp. July 15, 2017, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017, C1-09848 Exp. March 4, 2018, C1-10382 Exp. May 17, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, OR-04730 Exp. October 29, 2018, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017 and C1-09848 Exp. March 4, 2018
- Product
- OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers…
- Recalling firm
- Oscor, Inc.
- Quantity
- 110
- 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)