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U.S. Department of Health and Human Services

Class 2 Device Recall FREEDOMAIRE(R) HELMET SYSTEM WITH BELT

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 Class 2 Device Recall FREEDOMAIRE(R) HELMET SYSTEM WITH BELTsee related information
Date Initiated by FirmMarch 10, 2015
Date PostedMarch 27, 2015
Recall Status1 Terminated 3 on January 21, 2017
Recall NumberZ-1340-2015
Recall Event ID 70721
510(K)NumberK001082 K910515 
Product Classification Gown, surgical - Product Code FYA
ProductFREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
Code Information Lot Numbers: C9272 and C10078
Recalling Firm/
Manufacturer		 Microtek Medical Inc
602 N Lehmberg Rd
Columbus MS 39702-4406
For Additional Information ContactRoman Blahoski
651-250-4385
Manufacturer Reason
for Recall		This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
FDA Determined
Cause 2		Error in labeling
ActionThe firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: recall@ecolab.com RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email; customerservice@microtekmed.com.
Quantity in Commerce11 units
DistributionUS (nationwide) Distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FYA
510(K)s with Product Code = FYA
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