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U.S. Department of Health and Human Services

Class 2 Device Recall Stackhouse laser resistant suction probe

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  Class 2 Device Recall Stackhouse laser resistant suction probe see related information
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  
Product Classification Apparatus, exhaust, surgical - Product Code FYD
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
For Additional Information Contact Elizabeth Jolly
888-844-0988
Manufacturer Reason
for Recall		 Product labeled as sterile was distributed without sterilization.
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
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) Database 510(K)s with Product Code = FYD and Original Applicant = STACKHOUSE, INC.
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