Ethicon Recalls VICRYL RAPIDE Suture Lots Due to Tensile Failure
Ethicon is recalling 25 lots of VICRYL RAPIDE suture because the material failed knot tensile strength testing during quality control.
What this means for you
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 medical device failing tensile strength testing, which poses a risk of harm during surgical procedures, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ethicon, Inc. is recalling 25 lots of Coated VICRYL RAPIDE (Polyglactin 910) Suture. The recall was initiated on August 17, 2017, after suture damage was identified during finished goods testing. Subsequent investigation revealed that the suture also failed knot tensile strength testing.
The affected products were distributed nationally and internationally. The recall involves specific lot codes and product configurations, including various sizes (2-0 and 4-0) and needle types. The total quantity involved is 129,372 units.
Healthcare providers and facilities should stop using the affected lots and contact Ethicon for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Coated VICRYL RAPIDETM (Polyglactin 910) Suture
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Suture
- Affected units
- 129,372
Distribution
Distribution scope not specified by the agency.
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