MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Nu

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: 00-399027M , Lot Number 19GLA310 ; 00-399027M , Lot Number 19KLA520 ; 00-399027M , Lot Number 19LLA487 ; 00-399027M , Lot Number 20LLA663 ; 00-399027M , Lot Number 21JLA024 ; 00-399027M , Lot Number 21KLA330 ; 00-399027M , Lot Number 22GLA379 ; 00-399027M , Lot Number 22HLA991 ; 00-399027M , Lot Number 23FLA497 ; 00-399027M , Lot Number 23GLA579 ; CDS940242I , Lot Number 19BBK957 ; CDS940242I , Lot Number 19KBO521 ; CDS940242I , Lot Number 20ABP687 ; CDS940242I , Lot Number 20BBW841 ; CDS940242I , Lot Number 20EBC100 ; CDS940242I , Lot Number 20EBD870 ; CDS940242I , Lot Number 20EBI718 ; CDS940242I , Lot Number 21BBM845 ; CDS940242I , Lot Number 21DBU612 ; CDS940859J , Lot Number 19BBN781 ; CDS940859J , Lot Number 19CBI613 ; CDS940859J , Lot Number 19DBF963 ; CDS940859J , Lot Number 19FBF630 ; CDS940859J , Lot Number 19FBZ846 ; CDS940859J , Lot Number 19KBX776 ; CDS940859J , Lot Number 20ABJ911 ; CDS940859J , Lot Number 20ABX308 ; CDS940859J , Lot Number 20DBB231 ; CDS940869U , Lot Number 22JBA443 ; CDS940869U , Lot Number 22JBR468 ; CDS940869U , Lot Number 22KBM258 ; CDS940869U , Lot Number 23ABM583 ; CDS940869U , Lot Number 23EBO018 ; CDS940869U , Lot Number 23FBQ994 ; CDS940869U , Lot Number 23IBJ529 ; CDS940869U , Lot Number 23IBQ730 ; CDS940869U , Lot Number 23JBT822 ; CDS940869U , Lot Number 24ABP580 ; CDS940960I , Lot Number 19ABS109 ; CDS940960I , Lot Number 19CBJ215 ; CDS940960I , Lot Number 19DBT115 ; CDS940960I , Lot Number 19EBZ737 ; CDS940960I , Lot Number 19GBF7

Source

Official record: FDA (Device enforcement) ↗

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