Device product
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Z-1611-2013
Product summary
- Event
- Event 65397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1611-2013
Official wording
Reason: Medical devices were incorrectly labeled with extended expiration dates.
Code information: Lot MM27
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Labeling or packaging
incorrectly labeled