Ethicon Recalls DERMABOND PRINEO Skin Closure System Lots
Ethicon is recalling specific lots of the DERMABOND PRINEO Skin Closure System because the adhesive may not dry within the specified time and may fall off.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (failure to dry) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ethicon, Inc. is recalling specific lots of the DERMABOND PRINEO Skin Closure System. The product is intended for topical application to hold closed easily approximated skin edges of wounds from surgical incisions and simple lacerations. The recall involves 20,090 eaches (10,545 units) that were distributed nationwide in the United States.
The recall was initiated because Ethicon discovered that specific lots of the system may not dry within the specified time after proper application. As a result, the device may fall off. The affected lots are identified by the following codes: LEJ230, LEJ246, LEJ259, LEJ368, LGP375, LGP605, LGP606, LGP675, LGP814, LGR689, LGR710, LGR756, LHH468, LHH469, LHH560, LHH608, LHH686, LHH784, LHP498, LHP599, LHP602, and LHP868.
Consumers and healthcare providers should check their inventory for the affected lot codes. If the product is found, it should be removed from use and returned to Ethicon, Inc. according to the instructions provided by the manufacturer.
The recalled product
- Product
- DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple…
- Manufacturer
- Ethicon, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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