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Recall Observatory FDA recall evidence

Device 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 VCPB946H

Z-2145-2024

May 10, 2024

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 94643
Status
Ongoing
Classification
Class II
Quantity
55296 units
Official record key
device-enforcement:Z-2145-2024

Official wording

Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Code information: GTIN: 10705031051546 10705031052147 10705031053038 10705031054370 10705031054394 10705031054677 10705031150492 10705031056329 10705031056725 10705031150119 10705031150287 10705031150447 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility compromised