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Recall Observatory FDA recall evidence

Device product

Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Z-0191-2015

October 08, 2014

Class II

Product summary

Firm
Davol, Inc., Subs. C. R. Bard, Inc.
Event
Event 69464
Status
Terminated
Classification
Class II
Quantity
78 units
Official record key
device-enforcement:Z-0191-2015

Official wording

Reason: The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

Code information: Lot# HUYD0176

Distribution pattern: US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.