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 VCPB946H
Reported: June 26, 2024 Initiated: May 10, 2024 #Z-2145-2024
Product Description
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 VCPB946H
Reason for Recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 55296 units
- Distribution
- Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
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 VCPB946H. Recalled by Ethicon, Inc.. Units affected: 55296 units.
Why was this product recalled? ▼
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2024. Severity: Moderate. Recall number: Z-2145-2024.
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