FDA Device recall Z-1798-2017
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure by Windstone Medical Packaging, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1798-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-16 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
Product
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Reason
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.
Identifiers
| code_info | Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1798-2017%22
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