Device product
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B
Z-1619-2025
Product summary
- Event
- Event 96510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 222 units
- Official record key
device-enforcement:Z-1619-2025
Official wording
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Code information: 1) DYNJ40229A, UDI-DI: 10889942670482(each), 40889942670483(case), Lot Number: 24JBM438; 2) OPK382N, UDI-DI: 10889942686704(each), 40889942686705(case), Lot Number: 24JBN001; 3) DYNJ46723B, UDI-DI: 10889942747405(each), 40889942747406(case), Lot Number: 24JBQ891
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Derived failure modes
-
Unknown
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.