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Class 2 Device Recall Stretch gauze |
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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
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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
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Manufacturer Reason for Recall |
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
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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
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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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