Device product
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
Z-1477-2015
Product summary
- Event
- Event 70369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2650
- Official record key
device-enforcement:Z-1477-2015
Official wording
Reason: Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information: 1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101
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.