Class 2 Device Recall THOMAS by Gardner Denver, MEDIPUMP(R) Aspirator, Model 1243

• Date Initiated by Firm: June 04, 2015
• Date Posted: July 20, 2015
• Recall Status: Terminated on August 09, 2016
• Recall Number: Z-2151-2015
• 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 1243 Product Usage: medical aspirator
• Code Information: Serial numbers 2122-2629
• 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: 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: 508 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