Device product
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
Z-0813-2016
Product summary
- Event
- Event 73224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60
- Official record key
device-enforcement:Z-0813-2016
Official wording
Reason: Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
Code information: lot - 1529300018
Distribution pattern: US Distribution to CA., and Internationally to Canada.
Derived failure modes
-
Unknown
Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.