FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is int

FDA device recall Z-1339-2015 · posted 2015-03-27 · Terminated

Recall details

Recalling firm

Microtek Medical Inc

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.

Action taken

The 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.

Root cause

Error in labeling

Status

Terminated

Product code

FYA

Quantity affected

153 Units

Distribution

US (nationwide) Distribution.

Date initiated

2015-03-10

Date posted

2015-03-27

Date terminated

2017-01-21

Location

Columbus, MS

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