FDA recall Z-1611-2025

Product

Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5) PACK VAGINAL DELIVERY, Model Number: HM190A; 6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B; 7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B; 9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C; 10) VAGINAL DEL PK, Model Number: DYNJ65689; 11) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 12) L&D PACK-LF, Model Number: DYNJ0731657M; 13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B; 14) VAD ACCESS, Model Number: DYNJ24276C; 15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304; 16) VAGINAL DELIVERY CDS, Model Number: CDS982762I; 17) VAGINAL DELIVERY, Model Number: DYNJ903796C; 18) VAGINAL DELIVERY PACK, Model Number: DYNJ4

Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-03-03

Report date

2025-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2025