Device product
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Z-1467-2015
Product summary
- Event
- Event 70369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,200
- Official record key
device-enforcement:Z-1467-2015
Official wording
Reason: Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information: 1304035, 1407046, 1410111D
Distribution pattern: Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
Derived failure modes
-
Unknown
Potential for leaking caused by insufficient bond between needleless device and female luer.