Device product
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
Z-2894-2016
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 74892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78069 sets
- Official record key
device-enforcement:Z-2894-2016
Official wording
Reason: Administration Set potential filter leaking
Code information: Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Administration Set potential filter leaking