Device recall: Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general…
Class II FDA enforcement event 76774. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Windstone Medical Packaging, Inc. started this device recall on 16 Mar 2017. The firm address in the FDA record is in Billings, MT. FDA put the recall in Class II. FDA event 76774 has 18 product records. The first FDA enforcement report date is 19 Apr 2017. The record gives the status Terminated, with the termination date 6 Jun 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Recalling firm
Windstone Medical Packaging, Inc., Billings, MT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1783-2017 | Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure | 4,065 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1784-2017 | Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure | 990 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1785-2017 | 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 | 7,508 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1786-2017 | Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure | 164 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1787-2017 | Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure | 172 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1788-2017 | Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure | 1,170 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1789-2017 | ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure | 16 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1790-2017 | Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure | 1,520 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1791-2017 | Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure | 1,330 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1792-2017 | Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure | 260 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1793-2017 | Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure | 700 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1794-2017 | Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure | 169 packs | Class II | Terminated | 19 Apr 2017 |
| Z-1795-2017 | Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure | 12 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1796-2017 | Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure | 376 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1797-2017 | PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure | 20 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1798-2017 | Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure | 500 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1799-2017 | Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure | 440 kits | Class II | Terminated | 19 Apr 2017 |
| Z-1800-2017 | Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure | 100 kits | Class II | Terminated | 19 Apr 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 18Median of the firm: 3
- Events of the firm on the register
- 20
Other events of the firm
Official channels
- FDA enforcement report Z-1783-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 76774. https://recallregister.com/fda/ii/76774/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- What quantity of product is in FDA event 76774?
- The event has 18 product records. The first record gives this quantity:
4,065 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.