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U.S. Department of Health and Human Services

Class 2 Device Recall THOMAS by Gardner Denver, MEDIPUMP(R) Aspirator, Model 1242

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  Class 2 Device Recall THOMAS by Gardner Denver, MEDIPUMP(R) Aspirator, Model 1242 see related information
Date Initiated by Firm June 04, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on August 09, 2016
Recall Number Z-2150-2015
Recall Event ID 71569
510(K)Number K965059  
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
Product THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242

Product Usage:
medical aspirator
Code Information Serial numbers 3831-4200
Recalling Firm/
Manufacturer		 Gardner Denver Thomas Inc
4601 Central Ave
Monroe LA 71203-6003
For Additional Information Contact Theresa West
318-338-5038
Manufacturer Reason
for Recall		 Vacuum pump may not perform to specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423.
Quantity in Commerce 370 units
Distribution Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
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 = JCX and Original Applicant = THOMAS INDUSTRIES
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