Device product
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Z-2212-2016
Product summary
- Event
- Event 74465
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10
- Official record key
device-enforcement:Z-2212-2016
Official wording
Reason: BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
Code information: Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
Distribution pattern: Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Derived failure modes
-
Unknown
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs