MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF,

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: BT1095 , Lot Number 21HBO851 ; BT1095 , Lot Number 21JBA498 ; BT1095 , Lot Number 21KBS041 ; BT1095 , Lot Number 21LBI316 ; BT1095 , Lot Number 22IBE255 ; BT1095 , Lot Number 23CBL036 ; BT1095 , Lot Number 23DBE633 ; BT1095 , Lot Number 21ABU603 ; MNS5070, Lot Number 23LBC489; MNS5070, Lot Number 23HBL700; MNS5070, Lot Number 23EBJ365; SPEC0058A, Lot Number 2018110290; DYNDH1142A, Lot Number 2018120590; SPEC0130B, Lot Number 2018121290; SPEC0058A, Lot Number 2019012490; DYNDH1093, Lot Number 2019012490; SPEC0130B, Lot Number 2019020590; DYNDH1227A, Lot Number 2019020590; DYNDH1304A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDH1227A, Lot Number 2019040990; DYNDL1250C, Lot Number 2019040990; DYNDA2080, Lot Number 2019040990; SPEC0058A, Lot Number 2019060690; SPEC0130B, Lot Number 2019062890; SPEC0058A, Lot Number 2019070290; DYNDH1359, Lot Number 2019070290; MNS3355, Lot Number 2019062890; SPEC0130B, Lot Number 2019081590; SUT4020, Lot Number 2019081590; SPEC0265A, Lot Number 2019081590; DYNDH1349, Lot Number 2019081590; DYNDH1304A, Lot Number 2019112190; SPEC0196B, Lot Number 2019112190; DYNDH1349, Lot Number 2019112190; SPEC0130B, Lot Number 2019121190; DYNDH1496, Lot Number 2019122790; DYNDH1496, Lot Number 2020013190; DYNDH1496, Lot Number 2020120290; DYNDH1496, Lot Number 2021022590; SPEC0130C, Lot Number 2021051890; MNS6496, Lot Number 2021051890; SPEC0130C, Lot Number 2021071290; SPEC0130C, Lot Number 2021082490; SPEC0130C, Lot Number 2021091390; DYNDH

Source

Official record: FDA (Device enforcement) ↗

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