Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns
Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to ensure sterility assurance, which poses a risk of infection (risk-of-harm), but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling PERMA-HAND Silk Suture (siliconized black braided) because the company is unable to ensure that the products meet the expected sterility assurance level for sterile products. The recall involves 2,508 units of the suture, which are distributed nationwide.
The affected products are identified by specific product codes and lot numbers with expiration dates ranging from July 2018 to January 2019. The source text does not report any illnesses or injuries associated with the use of these sutures.
Healthcare providers and facilities should stop using the affected sutures and contact Ethicon for further instructions or a refund. Consumers should not use these medical devices and should return them to the point of purchase or the manufacturer.
The recalled product
- Product
- Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
- Manufacturer
- Ethicon, Inc.
- Affected units
- 2,508
Distribution
Distributed nationwide across the United States.
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