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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Windstone Medical Packaging, Inc.: AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Agency Publication Date: April 11, 2017
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Affected Products

Product: Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 76819 76820 78070 78533 78534 78535 79189 79972 80673 80674 80696 81600 82230 83093 83094 83585 83899 84580 85193 86565 86956 87679 88237 88915 88917 89946 95370 95574 95575 96215 96720 97384 97669 99621 99816 99881 101220

Lot Numbers:
numbers
Product: Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 77429 79999 81143 81960 84055 84556 85169 85550 86501 87632 87819 96056 96963 97873 98741 99416 99763 100278 101449

Lot Numbers:
numbers
Product: Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 63660 64459 65292 65897 65898 66764 66765 66770 67186 67187 67403 67867 67868 68184 68858 69648 69649 71075 71076 71077 71472 71950 71951 71952 72496 72497 72498 74246 74623 74985 75511 75512 75583 75904 76936 77245 77481 77591 78638 82162 82430 82583 82952 82954 82955 82956 82957 83400 83401 83855 83856 83857 83858 83904 84167 85095 85475 85944 86233 86234 86235 86593 86788 86925 87176 87552 87616 87721 88020 88234 88708 88709 89240 89643 89978 94699 95340 95341 95671 95873 96086 96372 96651 96847 96848 97636 97905 97985 98071 98228 98229 98585 98586 98587 98775 98826 98977 99442 99443 99587 99803 100091 100092 100155 100312 100313 100698 100699 101691 101692 101926 101927 102049 102139 102361

Lot Numbers:
numbers
Product: Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 64496 70752 79598 79966 82199 84036 85170 86682 87625 88001 89215 96462 100885

Lot Numbers:
numbers
Product: Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 66434 67357 67740 68573 72552 72934 73659 75891 82964 84240 84810 88958 96250 99637

Lot Numbers:
numbers
Product: Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 75870 78661 79154 81580 81800 83500 83594 83680 84118 84262 86073 86485 86887 87119 89180 95109 95422 95809 96760 97589 98512 99060 100410 101234

Lot Numbers:
numbers
Product: ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 72702 and 78567

Lot Numbers:
numbers
Product: Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 62980 63106 63387 63825 63826 64186 64490 64584 65937 75122 75329 77010 77089 77480 77664 78265 78312 78499 79042 79211 79944 79945 80709 80994 82316 82537 82538 82931

Lot Numbers:
numbers
Product: Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 62736 63388 63389 64189 64190 64586 65070 65171 65307 65714 65715 66342 66343 67079 67080 68165 68166 68234 68641 69264 69536 69545

Lot Numbers:
numbers
Product: Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 100960 103358 79099 81317 82664 82900 85028 86965 88297 89067 89311 94809 95531 98618 99932

Lot Numbers:
numbers
Product: Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 81885 84227 89474 98076 99390

Lot Numbers:
numbers
Product: Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 87223 88773 89837 95552 97215 97765 100154 100984 102837

Lot Numbers:
numbers
Product: Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure

Lot number: 101180

Lot Numbers:
number
Product: Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 76028 76762 77415 77811 80676 81907 82972 83238 84514 86860 88156 89013 89567 94566 95941 97769 98479 99356 101279 102974

Lot Numbers:
numbers
Product: PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 78709 84777 103152

Lot Numbers:
numbers
Product: Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020

Lot Numbers:
numbers
Product: Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 75908 78658 79157 79577 81959 83285 84916 85168 86500 87319 88343 88984 89749 96802 99415 102487

Lot Numbers:
numbers
Product: Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure

Lot numbers: 84384 85615 96957 99402

Lot Numbers:
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76774
Status: Resolved
Manufacturer: Windstone Medical Packaging, Inc.
Manufactured In: United States
Units Affected: 18 products (4,065 kits; 990 kits; 7,508 kits; 164 kits; 172 kits; 1,170 kits; 16 kits; 1,520 kits; 1,330 kits; 260 kits; 700 kits; 169 packs; 12 kits; 376 kits; 20 kits; 500 kits; 440 kits; 100 kits)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.