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

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4)

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: AM160B , Lot Number 19DBG798 ; AM160B , Lot Number 19DBT073 ; AM160B , Lot Number 19GBK115 ; AM160B , Lot Number 19TBB002 ; AM160B , Lot Number 19IBN286 ; AM160B , Lot Number 19KBF062 ; AM160C , Lot Number 21FBM171 ; AM160C , Lot Number 20ABB878 ; AM160C , Lot Number 20BBW406 ; AM160C , Lot Number 20CBA975 ; AM160C , Lot Number 20DBD025 ; AM160C , Lot Number 20GBG950 ; AM160C , Lot Number 20HBV795 ; AM160C , Lot Number 21BBF298 ; AM160C , Lot Number 21BBF425 ; CDS820031I , Lot Number 19BBK847 ; CDS820031I , Lot Number 19CBE063 ; CDS820031J , Lot Number 21FBL439 ; CDS820031J , Lot Number 21GBE677 ; CDS820031J , Lot Number 21JBF745 ; CDS820031J , Lot Number 21JBN716 ; CDS820031J , Lot Number 21JBY908 ; CDS820031J , Lot Number 21KBP597 ; CDS820031J , Lot Number 21WBA979 ; CDS820031J , Lot Number 19DBM904 ; CDS820031J , Lot Number 19EBM237 ; CDS820031J , Lot Number 19FBO038 ; CDS820031J , Lot Number 19GBF747 ; CDS820031J , Lot Number 22IBI048 ; CDS820031J , Lot Number 22KBF508 ; CDS820031J , Lot Number 22KBN688 ; CDS820031J , Lot Number 19JBC701 ; CDS820031J , Lot Number 19JBU877 ; CDS820031J , Lot Number 23ABE785 ; CDS820031J , Lot Number 19JBZ086 ; CDS820031J , Lot Number 23BBR695 ; CDS820031J , Lot Number 20BBK590 ; CDS820031J , Lot Number 20BBS508 ; CDS820031J , Lot Number 20BBZ094 ; CDS820031J , Lot Number 23IBH234 ; CDS820031J , Lot Number 20FBA127 ; CDS820031J , Lot Number 23JBD093 ; CDS820031J , Lot Number 23JBW122 ; CDS820031J , Lot Number 20GBK469 ; CDS820031J , Lot Num

Source

Official record: FDA (Device enforcement)

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

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