FDA recall Z-0174-2025

Product

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PACK, REF DYNJ17486I; 12) DELIVERY PACK, REF DYNJ24339K; 13) DELIVERY PACK, REF DYNJ26935A; 14) DELIVERY PACK, REF DYNJ26935A; 15) OB/DELIVERY ROOM PACK, REF DYNJ27262F; 16) VAGINAL DELIVERY TRAY, REF DYNJ27275; 17) VAGINAL DELIVERY, REF DYNJ28437F; 18) OB PACK, REF DYNJ31817K; 19) OB PACK, REF DYNJ31817K; 20) OB PACK, REF DYNJ36010F; 21) OB PACK, REF DYNJ38804G; 22) VAGINAL PACK, REF DYNJ40037A; 23) VAGINAL DELIVERY, REF DYNJ40170A; 24) VAG RECTAL PACK BWH-LF, REF DYNJ416

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Key facts

Status

Ongoing

Initiation date

2024-09-04

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2025