FDA-Device2026-07-08Class I

A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit

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.

Sold states
US Nationwide distribution in the states of PA, GA, CA, WA.
Affected count
200 units
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2026

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