Skip to content
Recall Observatory FDA recall evidence

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

January 15, 2015

Class II

Product summary

Firm
Churchill Medical Systems, Inc.
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

    reason.no_named_rule · v1.0.0

    Potential for leaking caused by insufficient bond between needleless device and female luer.