medical Class II Updated 2024-10-30

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand medical procedure convenience kits, labeled as

Recalled Product

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, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13) CATARACT PACK, REF DYNJ49412B; 14) CATARACT PACK, REF DYNJ50948A; 15) CATARACT PACK, REF DYNJ50948A; 16) CATARACT DR MALONE PACK, REF DYNJ51590A; 17) CATARACT DR MALONE PACK, REF DYNJ51590A; 18) CUSTOM EYE TRAY, REF DYNJ51821B; 19) EYE SURGERY PACK, REF DYNJ53097C; 20) CATARACT KIT, REF DYNJ53944; 21) EYE PACK, REF DYNJ54847D; 22) PK, OPHTH-EYE, REF DYNJ55070B; 23) EYE PACK, REF DYNJ55320D; 24) PK, OPHTH-RETINA, REF DYNJ59253B; 25) RETINA PACK, REF DYNJ60515; 26) ASED KIT, REF DYNJ60745D; 27) CATARACT PACK, REF DYNJ61321B; 28) EYE PACK, REF DYNJ61862A; 29) CATARACT PACK DR FREDERICK, REF DYNJ63163; 30) CATARACT DR ESTOPINAL, REF DYNJ63164; 31) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 32) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 33) HMSL EYE PACK, REF DYNJ64537A; 34) EYE PACK, REF DYNJ65271C; 35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832; 36) BASIC CATARACT PACK, REF DYNJ69165D; 37) BASIC CATARACT PACK, REF DYNJ69165D; 38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082; 39) CATARACT PACK WITH NO TUB, REF DYNJ80232; 40) RETINA PACK, REF DYNJ80483; 41) RETINA PACK, REF DYNJ81640; 42) WESTFALL OCCUPLASTY, REF DYNJ81796A; 43) EYE PACK, REF DYNJ83799C; 44) OPHTHALMIC PACK, REF DYNJ85275; 45) CATARACT, REF DYNJ908059A; 46) EYE TRAY 1-LF, REF LLSCAEYE01A; 47) PHACO PACK, REF LYN011PHNHD; 48) PHACO PACK, REF LYN011PHNHD; 49) SPECIALTY BESSER PACK, REF LYN023BPSSD; 50) SPECIALTY BESSER PACK, REF LYN023BPSSD; 51) SPECIALTY BESSER PACK, REF LYN023BPSSD; 52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 54) OPHTHALMIC PACK, REF LYN023OPSOB; 55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB; 56) BASIC CATARACT PACK, REF LYN030BCSDB; 57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA; 58) AIKEN CATARACT PACK II, REF LYN030CTAKG; 59) AIKEN CATARACT PACK II, REF LYN030CTAKG; 60) AIKEN CATARACT PACK II, REF LYN030CTAKG; 61) VA EYE II-LF, REF LYN030VAEYA; 62) VA EYE II-LF, REF LYN030VAEYA; 63) CATARACT PACK, REF LYN035CTSEC; 64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 66) OPHTHALMIC PACK, REF LYN041OPFCC; 67) OPHTHALMIC PACK, REF LYN041OPFCC; 68) OPHTHALMIC PACK, REF LYN041OPFCC; 69) OPHTHALMIC PACK, REF LYN041OPFCC; 70) CATARACT PACK, REF LYN042CPFEG; 71) OPTHALMIC PACK-LF, REF PHS529724000B; 72) CATARACT PACK, REF VAL001CPMEB; 73) CATARACT PACK, REF VAL001CPMEB; 74) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 75) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA; 77) CATARACT PACK, REF VAL009CAAHC; 78) RENAISSANCE CAT PACK, REF VAL009CAREA; 79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA; 80) CATARACT PACK, REF VAL009CTSGA; 81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC; 82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA; 83) RENAISSANCE VIT PACK, REF VAL009VIREA; 84) CATARACT PACK APERTURE, REF VAL011CTVAA; 85) OPHTHALMIC PACK, REF VAL022BSOMD; 86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD; 87) EYE PACK, REF VAL024EYTRB; 88) CATARACT PACK, REF VAL026CTNFC; 89) EYE PACK, REF VAL029EYGSB; 90) INTRAOCULAR PACK, REF VAL031IOGCB; 91) CATARACT, REF VAL035CPAEC; 92) CATARACT PACK 2, REF VAL036CABRD; 93) BRINTON VISION ICL PACK, REF VAL037ICBVG; 94) EYE PACK, REF VAL038BSCID; 95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB; 96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA; 97) BOOZMAN HOF PACK 2, REF VAL042EYBHC; 98) CATARACT PACK WILD

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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), Lot Numbers: 23LBN087; 17) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers: 23KBE531; 18) REF DYNJ51821B, UDI/DI 40193489963374 (each), 10193489963373 (case), Lot Numbers: 23KBE568; 19) REF DYNJ53097C, UDI/DI 40889942721376 (each), 10889942721375 (case), Lot Numbers: 24ABC180; 20) REF DYNJ53944, UDI/DI 40889942450689 (each), 10889942450688 (case), Lot Numbers: 23LBR325; 21) REF DYNJ54847D, UDI/DI 40193489266659 (each), 10193489266658 (case), Lot Numbers: 23LBI510; 22) REF DYNJ55070B, UDI/DI 40193489800686 (each), 10193489800685 (case), Lot Numbers: 23LBU001; 23) REF DYNJ55320D, UDI/DI 40195327429219 (each), 10195327429218 (case), Lot Numbers: 24ABD339; 24) REF DYNJ59253B, UDI/DI 40193489269322 (each), 10193489269321 (case), Lot Numbers: 24ABB328; 25) REF DYNJ60515, UDI/DI 40193489510240 (each), 10193489510249 (case), Lot Numbers: 24ABE890; 26) REF DYNJ60745D, UDI/DI 40193489949309 (each), 10193489949308 (case), Lot Numbers: 24ABA754; 27) REF DYNJ61321B, UDI/DI 40193489794411 (each), 10193489794410 (case), Lot Numbers: 23KBF225; 28) REF DYNJ61862A, UDI/DI 40195327216826 (each), 10195327216825 (case), Lot Numbers: 23KBC772; 29) REF DYNJ63163, UDI/DI 40193489721585 (each), 10193489721584 (case), Lot Numbers: 23LBL330; 30) REF DYNJ63164, UDI/DI 40193489721592 (each), 10193489721591 (case), Lot Numbers: 23LBN120; 31) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers: 24ABC862; 32) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers: 23KBI662; 33) REF DYNJ64537A, UDI/DI 40195327518494 (each), 10195327518493 (case), Lot Numbers: 24ABC540; 34) REF DYNJ65271C, UDI/DI 40193489957946 (each), 10193489957945 (case), Lot Numbers: 23KBC696; 35) REF DYNJ66832, UDI/DI 40193489389051 (each), 10193489389050 (case), Lot Numbers: 23KBE083; 36) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers: 23LBP941; 37) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers: 23KBE571; 38) REF DYNJ80082, UDI/DI 40195327012008 (each), 10195327012007 (case), Lot Numbers: 24ABD342; 39) REF DYNJ80232, UDI/DI 40195327017065 (each), 10195327017064 (case), Lot Numbers: 23LBN193; 40) REF DYNJ80483, UDI/DI 40195327045341 (each), 10195327045340 (case), Lot Numbers: 24ABC583; 41) REF DYNJ81640, UDI/DI 40195327129478 (each), 10195327129477 (case), Lot Numbers: 23LBK169; 42) REF DYNJ81796A, UDI/DI 40195327570386 (each), 10195327570385 (case), Lot Numbers: 23LBN670; 43) REF DYNJ83799C, UDI/DI 40195327443932 (each), 10195327443931 (case), Lot Numbers: 23LBP953; 44) REF DYNJ85275, UDI/DI 40195327484690 (each), 10195327484699 (case), Lot Numbers: 24ABA128; 45) REF DYNJ908059A, UDI/DI 40195327125432 (each), 10195327125431 (case), Lot Numbers: 23LBT833; 46) REF LLSCAEYE01A, UDI/DI 40884389376981 (each), 10884389376980 (case), Lot Numbers: 23KBB457; 47) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers: 24ABD326; 48) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers: 24ABA918; 49) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 24ABA470; 50) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 23LBN465; 51) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 23KBF760; 52) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers: 24ABC586; 53) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers: 24ABD327; 54) REF LYN023OPSOB, UDI/DI 40889942375791 (each), 10889942375790 (case), Lot Numbers: 24ABD328; 55) REF LYN024CACSB, UDI/DI 40195327095735 (each), 10195327095734 (case), Lot Numbers: 23LBN673; 56) REF LYN030BCSDB, UDI/DI 40193489457965 (each), 10193489457964 (case), Lot Numbers: 24ABH583; 57) REF LYN030CPSSA, UDI/DI 40195327128549 (each), 10195327128548 (case), Lot Numbers: 23KBD385; 58) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 24ABA502; 59) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 23LBP443; 60) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 23LBQ089; 61) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers: 24ABA893; 62) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers: 24ABD329; 63) REF LYN035CTSEC, UDI/DI 40889942532026 (each), 10889942532025 (case), Lot Numbers: 23KBC621; 64) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers: 23LBQ090; 65) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers: 23KBD746; 66) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 24ABD867; 67) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23LBN722; 68) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23LBA842; 69) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23KBD251; 70) REF LYN042CPFEG, UDI/DI 40193489219372 (each), 10193489219371 (case), Lot Numbers: 23KBC622; 71) REF PHS529724000B, UDI/DI 40195327166022 (each), 10195327166021 (case), Lot Numbers: 23KBE642; 72) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers: 24ABE054; 73) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers: 23LBH892; 74) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers: 24ABN974; 75) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers: 23KBC653; 76) REF VAL003REPEA, UDI/DI 40889942968382 (each), 10889942968381 (case), Lot Numbers: 24ABF774; 77) REF VAL009CAAHC, UDI/DI 40195327260300 (each), 10195327260309 (case), Lot Numbers: 23KBB402; 78) REF VAL009CAREA, UDI/DI 40193489462242 (each), 10193489462241 (case), Lot Numbers: 23KBC624; 79) REF VAL009CATEA, UDI/DI 40889942872399 (each), 10889942872398 (case), Lot Numbers: 24ABA924; 80) REF VAL009CTSGA, UDI/DI 40193489577540 (each), 10193489577549 (case), Lot Numbers: 24ABA478; 81) REF VAL009EYDLC, UDI/DI 40195327302291 (each), 10195327302290 (case), Lot Numbers: 24ABE052; 82) REF VAL009RETGA, UDI/DI 40193489676991 (each), 10193489676990 (case), Lot Numbers: 23LBQ654; 83) REF VAL009VIREA, UDI/DI 40193489462259 (each), 10193489462258 (case), Lot Numbers: 24ABA925; 84) REF VAL011CTVAA, UDI/DI 40889942005568 (each), 10889942005567 (case), Lot Numbers: 23KBC625; 85) REF VAL022BSOMD, UDI/DI 40889942760214 (each), 10889942760213 (case), Lot Numbers: 23LBQ097; 86) REF VAL024CAIOD, UDI/DI 40193489491525 (each), 10193489491524 (case), Lot Numbers: 23KBB700; 87) REF VAL024EYTRB, UDI/DI 40193489426008 (each), 10193489426007 (case), Lot Numbers: 23LBN467; 88) REF VAL026CTNFC, UDI/DI 40193489458412 (each), 10193489458411 (case), Lot Numbers: 23LBA843; 89) REF VAL029EYGSB, UDI/DI 40193489550727 (each), 10193489550726 (case), Lot Numbers: 23KBT152; 90) REF VAL031IOGCB, UDI/DI 40889942307198 (each), 10889942307197 (case), Lot Numbers: 24ABA898; 91) REF VAL035CPAEC, UDI/DI 40889942537373 (each), 10889942537372 (case), Lot Numbers: 23KBE643; 92) REF VAL036CABRD, UDI/DI 40195327196159 (each), 10195327196158 (case), Lot Numbers: 23KBC657; 93) REF VAL037ICBVG, UDI/DI 40193489868136 (each), 10193489868135 (case), Lot Numbers: 23KBC628; 94) REF VAL038BSCID, UDI/DI 40888277761767 (each), 10888277761766 (case), Lot Numbers: 23KBC629; 95) REF VAL038CTECB, UDI/DI 40889942867883 (each), 10889942867882 (case), Lot Numbers: 23LBP453; 96) REF VAL041EPSWA, UDI/DI 40193489394550 (each), 10193489394559 (case), Lot Numbers: 24ABA469; 97) REF VAL042EYBHC, UDI/DI 40195327033249 (each), 10195327033248 (case), Lot Numbers: 23KBD595; 98) REF VAL046CAWCA, UDI/DI 40193489846721 (each), 10193489846720 (case), Lot Numbers: 23LBM013; 99) REF VAL047VIVOA, UDI/DI 40193489375122 (each), 10193489375121 (case), Lot Numbers: 23LBM392; 100) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers: 23LBQ099; 101) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers: 23KBC660; 102) REF VAL050CTFEI, UDI/DI 40193489368063 (each), 10193489368062 (case), Lot Numbers: 24ABA899; 103) REF VAL050EEPKB, UDI/DI 40195327267149 (each), 10195327267148 (case), Lot Numbers: 24ABA472; 104) REF VAL050ITKEA, UDI/DI 40195327134090 (each), 10195327134099 (case), Lot Numbers: 23KBK068; 105) REF VAL050REBOB, UDI/DI 40193489833653 (each), 10193489833652 (case), Lot Numbers: 24ABA477; 106) REF VAL050VIAHD, UDI/DI 40195327195565 (each), 10195327195564 (case), Lot Numbers: 23JBU308; 107) REF VAL054CAMAA, UDI/DI 40193489228114 (each), 10193489228113 (case), Lot Numbers: 23LBQ100; 108) REF VAL059DKSWB, UDI/DI 40193489667951 (each), 10193489667950 (case), Lot Numbers: 23KBE384; 109) REF VAL075EYLSA, UDI/DI 40889942804345 (each), 10889942804344 (case), Lot Numbers: 23LBP466; 110) REF VAL089EYRUA, UDI/DI 40193489438162 (each), 10193489438161 (case), Lot Numbers: 23LBP468
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