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Recall Observatory FDA recall evidence

Device product

PDS Plus Antibacterial (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: PDP304H PDP316H PDP341H

Z-2147-2024

May 10, 2024

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 94643
Status
Ongoing
Classification
Class II
Quantity
45828 units
Official record key
device-enforcement:Z-2147-2024

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: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA

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