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
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
sterility compromised