Z-2622-2026 Class I Ongoing
FDA device recall Z-2622-2026 was initiated by Windstone Medical Packaging, Inc. on May 21, 2026 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 45 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
Product Description
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of PA, GA, CA, WA.
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.