Device product
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Z-0787-2017
Product summary
- Event
- Event 75816
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,500
- Official record key
device-enforcement:Z-0787-2017
Official wording
Reason: Incorrect priming volume is printed on the device package.
Code information: 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
Distribution pattern: US distribution in the state of CA
Derived failure modes
-
Unknown
Incorrect priming volume is printed on the device package.