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Class 2 Device Recall Stackhouse laser resistant suction probe |
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Date Initiated by Firm |
May 25, 2010 |
Date Posted |
July 28, 2010 |
Recall Status1 |
Terminated 3 on August 12, 2010 |
Recall Number |
Z-2109-2010 |
Recall Event ID |
56130 |
510(K)Number |
K001082
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Product Classification |
Apparatus, exhaust, surgical - Product Code FYD
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Product |
MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device |
Code Information |
Lot Number C10133 |
Recalling Firm/ Manufacturer |
Microtek Medical Inc 602 N Lehmberg Rd Columbus MS 39702-4406
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For Additional Information Contact |
Elizabeth Jolly 888-844-0988
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Manufacturer Reason for Recall |
Product labeled as sterile was distributed without sterilization.
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FDA Determined Cause 2 |
Other |
Action |
The firm notified its consignees of the problem and requested return of the product by telephone on 05/25/2010. They followed with a letter dated on 06/03/2010 re: Product Removal stating the reason for the recall and confirming the receipt of the recalled product. For further information please contact (662) 244-3220 |
Quantity in Commerce |
2 cases of 10 units |
Distribution |
Nationwide distribution including the states of Montana and Georgia |
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, INC.
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