Ethicon Recalls VICRYL Sutures Due to Braid Fraying
Ethicon is recalling specific VICRYL sutures because braid fraying may reduce tensile strength. The recall covers 23,688 units distributed in the US and Puerto Rico.
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 involves a medical device with a defect that can lead to reduced tensile strength, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Ethicon, Inc. is recalling Coated VICRYL (Polyglactin 910) Sutures, 18" (45cm), Product Code J497H, Lot PGZ908. The recall involves 23,688 units of this synthetic absorbable sterile surgical suture.
The recall was initiated because some sutures in the affected lot may exhibit a small section of braid fraying. This defect can lead to reduced tensile strength at the frayed point, potentially compromising the suture's performance during surgical use.
The affected products were distributed domestically nationwide in the United States and Puerto Rico. Healthcare facilities and distributors should stop using the affected sutures and contact Ethicon for instructions on returning the product.
The recalled product
- Product
- Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
- Manufacturer
- Ethicon, Inc.
- Affected units
- 23,688
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 PGZ908
Distribution
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