FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect
Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.
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: FDA Class II recall of medical sutures with compromised sterility due to packaging defect. The hazard (infection risk) is potential rather than reported, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling VICRYL Plus Antibacterial (polyglactin 910) Sutures due to a defect on a specific packaging machine that resulted in holes in the primary packaging. The compromised packaging could allow the sterile product to become contaminated, potentially exposing patients to infection.
The recall affects approximately 55,296 units that were distributed worldwide, including throughout the United States, Puerto Rico, and in Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Israel, Japan, Kuwait, Mexico, New Zealand, Panama, Saudi Arabia, Singapore, Uruguay, and South Africa. Affected product codes are VCP196H, VCP417H, VCP602H, VCP603H, VCP662H, VCPB259H, and VCPB946H, with specific lot numbers identified by the FDA.
The recalled product
- Product
- VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
- Manufacturer
- Ethicon, Inc.
- Hazard
- packaging-defect
- sterility-compromise
- infection-risk
Distribution
Distributed nationwide across the United States.
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