Oscor Adelante Breezway 8f Straight S79cm D84cm recall
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart…
Why was Oscor Adelante Breezway 8f Straight 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: C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, OR-04708 Exp. August 19, 2018, C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, C1-09373 Exp. November 5, 2017, C1-09373 Exp. November 5, 2017, OR-04708 Exp. August 19, 2018, and C1-11734 Exp. October 5, 2018
- Product
- OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart…
- Recalling firm
- Oscor, Inc.
- Quantity
- 21
- 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)