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U.S. Department of Health and Human Services

Class 2 Device Recall Stretch gauze

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  Class 2 Device Recall Stretch gauze see related information
Date Initiated by Firm February 24, 2016
Create Date March 25, 2016
Recall Status1 Terminated 3 on July 08, 2016
Recall Number Z-1251-2016
Recall Event ID 73324
Product Classification Dressing, compression - Product Code MHW
Product IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use

To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
Code Information Lot 63927, expiration 2017-04
Recalling Firm/
Manufacturer		 Amd Ritmed
1200 Av 55e
Lachine Canada
Manufacturer Reason
for Recall		 Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
FDA Determined
Cause 2		 Process control
Action AMD Ritmed sent an Urgent - Medical Device Recall letter dated February 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine all stocks immediately to determine if any of the affected product is on hand. If so, please discontinue distributing the product immediately and promptly return. If customers further distributed any of the product, please immediately contact your accounts advise them of the recall situation, and have them return their outstanding recalled stocks to you. Return these stocks as indicated above. Please return the enclosed response form immediately providing the requested information by fax 1-866-871-3455 or by email: AMDCustomerservice@amdritmed.com. Customers with questions can call 1-800-445-0340 or email AMD Customer Service: AMDCustomerservice@amdritmed.com.
Quantity in Commerce 126 cases total (87 cases domestically and 39 cases internationally)
Distribution US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
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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