MEDLINE INDUSTRIES, LP - Northfield: Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216C

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: 8830 units Lot/code info: a) REF DYND150200S, UDI/DI 40195327387885 (each), 10195327387884 (case), Lot Numbers: 23LBK182; b) REF DYND150216CS, UDI/DI 40195327388059 (each), 10195327388058 (case), Lot Numbers: 23LBK183; c) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBO854; d) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBL067; e) REF DYND150218CS, UDI/DI 40195327388066 (each), 10195327388065 (case), Lot Numbers: 23LBL068; f) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23LBP852; g) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23KBK538; h) REF DYND150816, UDI/DI 40195327043064 (each), 10195327043063 (case), Lot Numbers: 23KBE406; i) REF DYND150816CS, UDI/DI 40195327149919 (each), 10195327149918 (case), Lot Numbers: 23KBU812; j) REF DYND150816S, UDI/DI 40195327149711 (each), 10195327149710 (case), Lot Numbers: 24ABA832; k) REF DYND150818CS, UDI/DI 40195327149926 (each), 10195327149925 (case), Lot Numbers: 23LBH302; l) REF DYND150818S, UDI/DI 40195327149889 (each), 10195327149888 (case), Lot Numbers: 23KBF923

UPC codes

40195327387885, 10195327387884, 40195327388059, 10195327388058, 40195327387366, 10195327387365, 40195327388066, 10195327388065, 40195327388004, 10195327388003, 40195327043064, 10195327043063, 40195327149919, 10195327149918, 40195327149711, 10195327149710, 40195327149926, 10195327149925, 40195327149889, 10195327149888

Source

Official record: FDA (Device enforcement) ↗

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