Date Initiated by Firm | June 08, 2016 |
Date Posted | December 08, 2016 |
Recall Status1 |
Terminated 3 on February 24, 2017 |
Recall Number | Z-0727-2017 |
Recall Event ID |
74368 |
Product Classification |
Dressing,wound,hydrophilic - Product Code NAC
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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 |
Code Information |
Lot 68408, expiration date 2018¿05 |
Recalling Firm/ Manufacturer |
Amd-Ritmed, Inc. 295 Fire Tower Dr Tonawanda NY 14150-5833
|
For Additional Information Contact | Dominique Abecassis 514-633-1111 Ext. 2309 |
Manufacturer Reason for Recall | The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis. |
FDA Determined Cause 2 | Material/Component Contamination |
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 contactus@amdritmed.com. |
Quantity in Commerce | US: 216 cases (200 dressings per case) |
Distribution | NY, MA, VA, TN |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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