Z-1783-2017Class II

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

Name: Z-1783-2017 Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a...
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 Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure 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-1783-2017
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 Kit, part numbers CAT1467AM and CAT1538(B. 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: 4,065 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: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1783-2017
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)