Home / Recalls / Amd-Ritmed, Inc. / Z-0727-2017

Z-0727-2017 Class II Terminated

Recalled by Amd-Ritmed, Inc. — Tonawanda, NY

Recall Details

Product Type: Devices
Report Date: December 14, 2016
Initiation Date: June 8, 2016
Termination Date: February 24, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US: 216 cases (200 dressings per case)

Product Description

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

Reason for Recall

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

Distribution Pattern

NY, MA, VA, TN

Code Information

Lot 68408, expiration date 2018¿05