Recall Z-0191-2015— Davol, Inc., Subs. C. R. Bard, Inc.

Name: FDA recall Z-0191-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-08

Class II · Terminated

Class II FDA medical device recall by Davol, Inc., Subs. C. R. Bard, Inc., initiated 2014-10-08, terminated 2015-12-23. It names one FDA 510(k) clearance: K092032. 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.. 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..

Recalling firm: Davol, Inc., Subs. C. R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Terminated: 2015-12-23
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K092032 — BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160Davol Inc., Sub. C. R. Bard, Inc.·cleared 2009-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.