Z-1785-2017Class II

Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged...

Name: Z-1785-2017 Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged...
Creator: Windstone Medical Packaging, Inc.
Published: 2017-03-16
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2017-03-16 / Terminated / root cause: manufacturing process

FDA source

Windstone Medical Packaging, Inc. began a recall of 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... on 2017-03-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1785-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-16
Posted: 2017-04-11
Terminated: 2017-06-06
Recalling firm: Windstone Medical Packaging, Inc.
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
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to [email protected]. Customers can call Aligned Medical Solutions at 321-527-7714.
Quantity in commerce: 7,508 kits
Distribution: Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1785-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1783-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1784-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1785-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1786-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1787-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1788-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1789-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1790-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1791-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1792-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1793-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1794-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1795-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1796-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1797-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1798-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1799-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11
Z-1800-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11

Product code FSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)