DePuy LifeLiner Gloves Recalled for Mispackaging
DePuy Orthopaedics is recalling LifeLiner Stick and Cut Resistant Gloves because right-handed packages contained left-handed gloves.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Category
- Medical Device — Surgical Gloves
- Hazard
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
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