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Terminated

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

FDA Recall Z-0727-2017 · Posted 2016-12-08

Recalling FirmAmd-Ritmed, Inc.
Recall StatusTerminated
Product CodeNAC
Date Initiated2016-06-08
Date Terminated2017-02-24
Product QuantityUS: 216 cases (200 dressings per case)

Reason for Recall

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

Firm Action

URGENT: MEDICAL DEVICE RECALL Letter (dated 6/8/2016) was e-mailed to the consignees on 6/8/2016. The recall is being conducted to the retail level. For questions. please contact AMD Customer Service by phone at 1-800-445-0340 or by e-mail at [email protected].

Root Cause

Material/Component Contamination

Distribution Pattern

NY, MA, VA, TN

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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