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Recall Observatory FDA recall evidence

Device product

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H

Z-2146-2024

May 10, 2024

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 94643
Status
Ongoing
Classification
Class II
Quantity
56952 units
Official record key
device-enforcement:Z-2146-2024

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 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 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