Device product
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) 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-2895-2016
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 74892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78063 sets
- Official record key
device-enforcement:Z-2895-2016
Official wording
Reason: Administration Set potential filter leaking
Code information: B2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595 B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Administration Set potential filter leaking