FDA-Device2016-12-14Class II

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

Amd-Ritmed, Inc.
Hazard

The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.

Sold states
NY, MA, VA, TN
Affected count
US: 216 cases (200 dressings per case)
Manufactured in
295 Fire Tower Dr, N/A, Tonawanda, NY, United States
Products
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2017

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