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FDA (Device enforcement)Recalled 2024-09-04class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4)

Hazard

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Details from the source

Reason for recall: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama. Quantity: 2740 units Lot/code info: 1) REF CDS982091I, UDI/DI 40193489741644 (each), 10193489741643 (case), Lot Numbers: 24BBA623; 2) REF CDS984492B, UDI/DI 40193489637183 (each), 10193489637182 (case), Lot Numbers: 24ABB114; 3) REF DYNJ0798129I, UDI/DI 40195327226511 (each), 10195327226510 (case), Lot Numbers: 23KBB859; 4) REF DYNJ30591I, UDI/DI 40193489962841 (each), 10193489962840 (case), Lot Numbers: 24ABD228; 5) REF DYNJ37171A, UDI/DI 40884389750620 (each), 10884389750629 (case), Lot Numbers: 23KBD998; 6) REF DYNJ40836F, UDI/DI 40195327059539 (each), 10195327059538 (case), Lot Numbers: 23LBQ627; 7) REF DYNJ44249J, UDI/DI 40195327483020 (each), 10195327483029 (case), Lot Numbers: 23KBE536; 8) REF DYNJ44349L, UDI/DI 40195327394531 (each), 10195327394530 (case), Lot Numbers: 23KBD353; 9) REF DYNJ44349M, UDI/DI 40195327564378 (each), 10195327564377 (case), Lot Numbers: 24ABA446; 10) REF DYNJ53200C, UDI/DI 40193489779371 (each), 10193489779370 (case), Lot Numbers: 23KBC298; 11) REF DYNJ53270C, UDI/DI 40193489812566 (each), 10193489812565 (case), Lot Numbers: 23KBA462; 12) REF DYNJ54610A, UDI/DI 40195327456451 (each), 10195327456450 (case), Lot Numbers: 24ABD026; 13) REF DYNJ55255C, UDI/DI 40195327493753 (each), 10195327493752 (case), Lot Numbers: 23KBD956; 14) REF DYNJ58979, UDI/DI 40889942914938 (each), 10889942914937 (case), Lot Numbers: 24ABD861; 15) REF DYNJ62927, UDI/DI 40193489700245 (each), 10193489700244 (case), Lot Numbers: 23LBQ806; 16) REF DYNJ63190A, UDI/DI 40193489304603 (each), 10193489304602 (cas

UPC codes

40193489741644, 10193489741643, 40193489637183, 10193489637182, 40195327226511, 10195327226510, 40193489962841, 10193489962840, 40884389750620, 10884389750629, 40195327059539, 10195327059538, 40195327483020, 10195327483029, 40195327394531, 10195327394530, 40195327564378, 10195327564377, 40193489779371, 10193489779370, 40193489812566, 10193489812565, 40195327456451, 10195327456450, 40195327493753, 10195327493752, 40889942914938, 10889942914937, 40193489700245, 10193489700244, 40193489304603, 10193489304602, 40195327151981, 10195327151980, 40195327207084, 10195327207083, 40195327341634, 10195327341633, 40195327220144, 10195327220143

Source

Official record: FDA (Device enforcement)

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

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