| 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
|
| 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
|
|
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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