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Recall Observatory FDA recall evidence

Device product

4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids

Z-1470-2015

January 15, 2015

Class II

Product summary

Firm
Churchill Medical Systems, Inc.
Event
Event 70369
Status
Terminated
Classification
Class II
Quantity
2200
Official record key
device-enforcement:Z-1470-2015

Official wording

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

Code information: 1303120 1305002 1306099

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.