MEDLINE INDUSTRIES, LP - Northfield: Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK,

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: 27,906 units Lot/code info: 1) REF DYNJ19492L, UDI/DI 40195327368587 (each), 10195327368586 (case), Lot Numbers: 24ABE741; 2) REF DYNJ22354L, UDI/DI 40195327239924 (each), 10195327239923 (case), Lot Numbers: 23LBN139; 3) REF DYNJ24573K, UDI/DI 40195327144303 (each), 10195327144302 (case), Lot Numbers: 23KBB931; 4) REF DYNJ30327A, UDI/DI 40193489997089 (each), 10193489997088 (case), Lot Numbers: 24ABB714; 5) REF DYNJ36868F, UDI/DI 40888277897060 (each), 10888277897069 (case), Lot Numbers: 23KBD160; 6) REF DYNJ40811A, UDI/DI 40888277014634 (each), 10888277014633 (case), Lot Numbers: 23KBE584; 7) REF DYNJ41769A, UDI/DI 40888277267825 (each), 10888277267824 (case), Lot Numbers: 23KBB744; 8) REF DYNJ41861, UDI/DI 40888277020741 (each), 10888277020740 (case), Lot Numbers: 23KBB746; 9) REF DYNJ43911, UDI/DI 40888277073617 (each), 10888277073616 (case), Lot Numbers: 23LBQ741; 10) REF DYNJ44748I, UDI/DI 40193489273459 (each), 10193489273458 (case), Lot Numbers: 23LBP074; 11) REF DYNJ45344G, UDI/DI 40195327402922 (each), 10195327402921 (case), Lot Numbers: 23LBU068; 12) REF DYNJ47275A, UDI/DI 40888277571946 (each), 10888277571945 (case), Lot Numbers: 24ABE470; 13) REF DYNJ49412B, UDI/DI 40889942935278 (each), 10889942935277 (case), Lot Numbers: 24ABD256; 14) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers: 24ABC786; 15) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers: 23KBA350; 16) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case)

UPC codes

40195327368587, 10195327368586, 40195327239924, 10195327239923, 40195327144303, 10195327144302, 40193489997089, 10193489997088, 40888277897060, 10888277897069, 40888277014634, 10888277014633, 40888277267825, 10888277267824, 40888277020741, 10888277020740, 40888277073617, 10888277073616, 40193489273459, 10193489273458, 40195327402922, 10195327402921, 40888277571946, 10888277571945, 40889942935278, 10889942935277, 40195327117550, 10195327117559, 40193489721387, 10193489721386, 40193489963374, 10193489963373, 40889942721376, 10889942721375, 40889942450689, 10889942450688, 40193489266659, 10193489266658, 40193489800686, 10193489800685

Source

Official record: FDA (Device enforcement) ↗

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