FDA recall Z-3009-2024

Product

Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ; 12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ; 13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ; 14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ; 15) ENDOSCOPY-LF, Pack Number DYNJ22890L ; 16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ; 17) ENDOSCOPY PACK, Pack Number DYNJ50594C ; 18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ; 19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ; 20) ENDOSCOPIC PACK , Pack Num

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3009-2024