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Recall Observatory FDA recall evidence

Device product

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

Z-2619-2026

May 21, 2026

Class I

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 99189
Status
Ongoing
Classification
Class I
Quantity
1080 kits
Official record key
device-enforcement:Z-2619-2026

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: US Nationwide distribution in the states of PA, GA, CA, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.