Z-1619-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 222 units
Product Description
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
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
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