Recall Z-1331-2013— DePuy Orthopaedics, Inc.

Class III · Terminated

Class III FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2013-05-08, terminated 2014-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.. Reason: LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves..

Recalling firm
DePuy Orthopaedics, Inc.
Classification
Class III
Status
Terminated
Initiated
2013-05-08
Terminated
2014-01-14
Firm location
Warsaw, IN, United States

Product description

DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.

Reason for recall

LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.

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