Device product
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Z-1475-2015
Product summary
- Event
- Event 70369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6850
- Official record key
device-enforcement:Z-1475-2015
Official wording
Reason: Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information: 1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D
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.