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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number D

Hazard

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.

Details from the source

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. Lot/code info: CDS981309O , Lot Number 19GBS426 ; CDS981309O , Lot Number 19JBE731 ; CDS981309O , Lot Number 19LBN327 ; CDS981309O , Lot Number 20BBE553 ; CDS981309O , Lot Number 20DBG947 ; CDS981309O , Lot Number 20GBU396 ; CDS984155F , Lot Number 19GBV870 ; CDS984155F , Lot Number 19JBX096 ; DYKE1112 , Lot Number 23LME611 ; DYKE1133A, Lot Number 22AMA243 ; DYKE1264 , Lot Number 22GME430 ; DYKE1264 , Lot Number 22HMA299 ; DYKE1389 , Lot Number 19DBL730 ; DYKE1389 , Lot Number 19DBN769 ; DYKE1389 , Lot Number 19VBA308 ; DYKE1389 , Lot Number 19KBI635 ; DYKE1389 , Lot Number 20ABU603 ; DYKE1856 , Lot Number 22JBU738 ; DYKE1856 , Lot Number 22LBC945 ; DYKE1856 , Lot Number 23ABJ226 ; DYKE1864B, Lot Number 23LBG919 ; DYNDA3058, Lot Number 23GBJ275 ; DYNDA3058, Lot Number 23JBJ971 ; DYNDA3058, Lot Number 23LBA980 ; DYNJ00339J , Lot Number 19LMB920 ; DYNJ00339J , Lot Number 20BMA093 ; DYNJ00339J , Lot Number 19DKA281 ; DYNJ00339J , Lot Number 19DKC903 ; DYNJ00339J , Lot Number 19GKA519 ; DYNJ00339J , Lot Number 19JKB148 ; DYNJ0396027I , Lot Number 19DDA509 ; DYNJ0426277J , Lot Number 19IMB754 ; DYNJ0426277J , Lot Number 20AMA124 ; DYNJ0426277J , Lot Number 20CMC692 ; DYNJ0426277J , Lot Number 20FMB816 ; DYNJ0426277J , Lot Number 20HMB568 ; DYNJ0426277J , Lot Number 20IMD473 ; DYNJ0426277J , Lot Number 21AMB951 ; DYNJ0426277J , Lot Number 21CMC718 ; DYNJ0426277J , Lot Number 21FMB061 ; DYNJ0426277J , Lot Number 19HKC356 ; DYNJ22661L , Lot Number 19HBO860 ; DYNJ22661L , Lot Number 19IBM436 ; DYNJ2

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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