Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3,
FDA device recall Z-1920-2008 · posted 2008-07-24 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).
- Action taken
- Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 311 US, 27 OUS
- Distribution
- Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
- Date initiated
- 2008-05-09
- Date posted
- 2008-07-24
- Date terminated
- 2012-05-08
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |