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Windstone Medical Packaging, Inc.: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

Medical DevicesSource: FDA (device) · Date: 2026-07-08

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Windstone Medical Packaging, Inc.
Product
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Reason / hazard
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Classification
Class I
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of PA, GA, CA, WA.
Recall initiated
2026-05-21
Code info
UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
Product quantity
1080 kits
Voluntary mandated
Voluntary: Firm initiated
City
Billings
State
MT
Country
United States
Event id
99189
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