Oscor Adelante Breezeway 8f C90¿ S79cm D84cm recall
OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers…
Why was Oscor Adelante Breezeway 8f 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: OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, C1-11635 Exp. September 29, 2018, OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, and C1-09412 Exp. December 1, 2017
- Product
- OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers…
- Recalling firm
- Oscor, Inc.
- Quantity
- 61
- 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)