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

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS78

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: AM310B , Lot Number 20BBX607 ; AM310B , Lot Number 20FBO876 ; AM310B , Lot Number 20HBG464 ; AM310B , Lot Number 20HBT869 ; AM310B , Lot Number 20JBW307 ; AM310B , Lot Number 20XBG776 ; CDS780161K , Lot Number 19ABJ175 ; CDS780161K , Lot Number 19CBC247 ; CDS780161K , Lot Number 19DBJ688 ; CDS780161L , Lot Number 21FBM662 ; CDS780161L , Lot Number 21JBO079 ; CDS780161L , Lot Number 21KBU620 ; CDS780161L , Lot Number 22DBN197 ; CDS780161L , Lot Number 22EBE676 ; CDS780161L , Lot Number 22GBA238 ; CDS780161L , Lot Number 19FBZ495 ; CDS780161L , Lot Number 22HBH827 ; CDS780161L , Lot Number 22JBA466 ; CDS780161L , Lot Number 22JBR842 ; CDS780161L , Lot Number 19IBA021 ; CDS780161L , Lot Number 22LBG736 ; CDS780161L , Lot Number 23ABC482 ; CDS780161L , Lot Number 19KBD885 ; CDS780161L , Lot Number 23BBK773 ; CDS780161L , Lot Number 23DBH567 ; CDS780161L , Lot Number 20BBA048 ; CDS780161L , Lot Number 23EBW865 ; CDS780161L , Lot Number 23FBR465 ; CDS780161L , Lot Number 20CBF643 ; CDS780161L , Lot Number 23HBF094 ; CDS780161L , Lot Number 20DBQ527 ; CDS780161L , Lot Number 20EBT660 ; CDS780161L , Lot Number 23JBG854 ; CDS780161L , Lot Number 23KBG199 ; CDS780161L , Lot Number 20GBQ310 ; CDS780161L , Lot Number 20HBW040 ; CDS780161L , Lot Number 20KBQ319 ; CDS780161L , Lot Number 20LBP102 ; CDS780161L , Lot Number 20LBQ550 ; CDS780161L , Lot Number 21CBI795 ; CDS780161L , Lot Number 21DBA543 ; CDS780161L , Lot Number 21EBA173 ; CDS780170R , Lot Number 21HBH210 ; CDS780170R , Lot Nu

Source

Official record: FDA (Device enforcement)

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

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