| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 04, 2024 |
|---|
| Date Posted | October 23, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0178-2025 |
|---|
| Recall Event ID |
95415 |
| Product Classification |
Eye tray - Product Code OJK
|
| 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 |
|---|
| Code Information |
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
|
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
866-359-1704 |
|---|
Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
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| Quantity in Commerce | 27,906 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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