Device product
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
Z-1473-2015
Product summary
- Event
- Event 70369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 129,500
- Official record key
device-enforcement:Z-1473-2015
Official wording
Reason: Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information: 1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D
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.