FDA-Device2026-07-08Class IPROCESSING DEFECT

A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit

OTHERNationwide distributionMedical devices
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.

Intended for
Adults
Illnesses reported
None reported
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, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2620-2026

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