The Recall Desk
LowFDA (Devices)·Z-1331-2013·Announced 2013-05-22

DePuy LifeLiner Gloves Recalled for Mispackaging

DePuy Orthopaedics is recalling LifeLiner Stick and Cut Resistant Gloves because right-handed packages contained left-handed gloves.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging error rather than a safety defect.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling DePuy LifeLiner Stick and Cut Resistant Gloves, Part No. 5200-68-000. The recall involves 180 gloves, with 120 distributed in the United States and the remainder distributed worldwide, including in the UK, Netherlands, and Canada.

The gloves are being recalled because cases and individual glove packages were mispackaged. Specifically, packaging labeled for right-handed, large-sized gloves contained left-handed, large-sized gloves. The source text notes that these gloves are designed to resist sticks and cuts but are not cut or puncture proof, and they are not required by any surgical technique.

The affected lot number is D12178C. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot - D12178C

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically: