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Class 2 Device Recall TUBING SET 7/8" X 6' WITH 1/4" x 24 TUBING |
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Date Initiated by Firm |
March 10, 2015 |
Date Posted |
March 27, 2015 |
Recall Status1 |
Terminated 3 on January 21, 2017 |
Recall Number |
Z-1346-2015 |
Recall Event ID |
70721 |
510(K)Number |
K001082 K910515
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Product Classification |
Apparatus, exhaust, surgical - Product Code FYD
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Product |
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites. |
Code Information |
Lot Numbers: C9225, C9232, C10239, C10285, C11042, C11129, C11136, C11172, C11209, C11216, C11279, C11300, C11332, C12010, C12023, C12102, C12157, C12194, C12215, C12251, C12290, C12339, C12348, C13008, C13056, C13057, C13092, C13157, C13164, C13176, C13268, C13295, C13308, C13337, C13340, C14027, C14057, C14094, C14135, C14195, C14209 C14232, C14238 |
Recalling Firm/ Manufacturer |
Microtek Medical Inc 602 N Lehmberg Rd Columbus MS 39702-4406
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For Additional Information Contact |
Roman Blahoski 651-250-4385
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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.
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FDA Determined Cause 2 |
Error in labeling |
Action |
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. |
Quantity in Commerce |
5889 units |
Distribution |
US (nationwide) Distribution. |
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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510(K) Database |
510(K)s with Product Code = FYD and Original Applicant = STACKHOUSE ASSOC. 510(K)s with Product Code = FYD and Original Applicant = STACKHOUSE, INC.
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