Device product
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
Z-1469-2015
Product summary
- Event
- Event 70369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2350
- Official record key
device-enforcement:Z-1469-2015
Official wording
Reason: Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information: 1303123 1305003 1305008 1305049 1306097
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.