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Recall Observatory FDA recall evidence

Device 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.

Z-1331-2013

May 08, 2013

Class III

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 65078
Status
Terminated
Classification
Class III
Quantity
180 gloves (120 gloves distributed in the US)
Official record key
device-enforcement:Z-1331-2013

Official wording

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.

Code information: Lot - D12178C

Distribution pattern: Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mispackaged