Device product
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Z-1484-2017
Product summary
- Event
- Event 76607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,700
- Official record key
device-enforcement:Z-1484-2017
Official wording
Reason: Incorrect priming volume printed on the device package.
Code information: 1610092D 1611091D 1612068D 1612074D
Distribution pattern: US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Derived failure modes
-
Unknown
Incorrect priming volume printed on the device package.