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

MEDLINE INDUSTRIES, LP - Northfield: See RES description

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. Quantity: 1,679,067 units in total Lot/code info: 00-398650AJ, Lot Number 23ABN193 ; 00-398650AJ, Lot Number 23ABN291 ; 00-398650AJ, Lot Number 23EBQ823 ; 00-398650AJ, Lot Number 23FBJ579 ; 00-398650AJ, Lot Number 23FBT136 ; 00-398650AJ, Lot Number 23IBB919 ; 00-398650AJ, Lot Number 23KBE097 ; 00-398650AJ, Lot Number 23LBS258 ; 00-398725AL, Lot Number 19BBA371 ; 00-398725AL, Lot Number 19CBE645 ; 00-398725AL, Lot Number 19DBR240 ; 00-398725AL, Lot Number 19EBK403 ; 00-398725AL, Lot Number 19FBU700 ; 00-398725AL, Lot Number 19GBR148 ; 00-398725AN, Lot Number 21FBS869 ; 00-398725AN, Lot Number 21JBN432 ; 00-398725AN, Lot Number 21LBK643 ; 00-398725AN, Lot Number 22ABX426 ; 00-398725AN, Lot Number 22BBR469 ; 00-398725AN, Lot Number 22CBU793 ; 00-398725AN, Lot Number 22OBM117 ; 00-398725AN, Lot Number 22EBK111 ; 00-398725AN, Lot Number 22GBJ289 ; 00-398725AN, Lot Number 22IBU378 ; 00-398725AN, Lot Number 22JBV752 ; 00-398725AN, Lot Number 22LBE100 ; 00-398725AN, Lot Number 23ABO369 ; 00-398725AN, Lot Number 23BBT199 ; 00-398725AN, Lot Number 23DBI838 ; 00-398725AN, Lot Number 23EBN543 ; 00-398725AN, Lot Number 23FBJ242 ; 00-398725AN, Lot Number 23HBB887 ; 00-398725AN, Lot Number 23IBG737 ; 00-398725AN, Lot Number 23JBD877 ; 00-398725AN, Lot Number 23KBT703 ; 00-398725AN, Lot Number 23LMC442 ; 00-399024AA, Lot Number 21GBA375 ; 00-399024AA, Lot Number 21HBS579 ; 00-399024AA, Lot Number 21VBC664 ; 00-399024AB, Lot Number 22ABB635 ; 00-399024AB, Lot Number 22BBO663 ; 00-399024AB, Lot Number 22EBG768 ; 00-399024AB, Lot Number 22IBI3

Source

Official record: FDA (Device enforcement)

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

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