Z-0191-2015 Class II Terminated
FDA device recall Z-0191-2015 was initiated by Davol, Inc., Subs. C. R. Bard, Inc. on October 8, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 23, 2015). Affected quantity: 78 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2014
- Initiation Date
- October 8, 2014
- Termination Date
- December 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
Code Information
Lot# HUYD0176