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U.S. Department of Health and Human Services

Class 2 Device Recall Conforming Stretch Gauze Bandages, Sterile

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  Class 2 Device Recall Conforming Stretch Gauze Bandages, Sterile see related information
Date Initiated by Firm March 30, 2016
Create Date July 15, 2016
Recall Status1 Terminated 3 on July 15, 2016
Recall Number Z-2213-2016
Recall Event ID 73696
Product Classification Bandage, elastic - Product Code FQM
Product AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case.

Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
Code Information Lot 64155, Expiration Date 2017-06
Recalling Firm/
Manufacturer		 Amd-Ritmed, Inc.
295 Fire Tower Dr
Tonawanda NY 14150-5833
For Additional Information Contact Ms. Dominique Abecassis
514-633-1111 Ext. 2309
Manufacturer Reason
for Recall		 The product lot did not meet sterility requirements based on FDA sampling and analysis.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm, AMD-Ritmed, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 3/30/2016 and Medical Device Recall Response Form to the US distributors/customers via e-mail. The letter described the product, problem and actions to be taken. The customers were instructed to examine your stock to determine if you have any; immediately discontinue distributing product; promptly return product via parcel post to Tonawanda/Buffalo warehouse, ATTENTION: RETURNED GOODS, AMD-Ritmed Inc., 295 Firetower Drive, Tonawanda, NY 14150; if you have further distributed the product, immediately contact your accounts, advise them of the recall situation and have them return their outstanding stock, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE-Acknowledgment & Receipt Form via email to : AMDCUSTOMERSERVICE@AMDRITMED.COM or fax to: 1-866-871-3455, ATTN: AMD-Ritmed Customer Service. If you have any questions, please contact us at (1-800-445-0340) or at AMD Customer Service AMDCustomerService@amdritmed.com.
Quantity in Commerce US: 107 cases (48 rolls per case)
Distribution US Distribution in states of: NY, CA, and 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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