Recall Z-0727-2017— Amd-Ritmed, Inc.
Class II · Terminated
Class II FDA medical device recall by Amd-Ritmed, Inc., initiated 2016-06-08, terminated 2017-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis..
- Recalling firm
- Amd-Ritmed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-08
- Terminated
- 2017-02-24
- Firm location
- Tonawanda, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.