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THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator

FDA device recall Z-2149-2015 · posted 2015-07-20 · Terminated

Recall details

Recalling firm
Gardner Denver Thomas Inc
Reason for recall
Vacuum pump may not perform to specification.
Action taken
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.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
JCX
Quantity affected
160 units
Distribution
Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
Date initiated
2015-06-04
Date posted
2015-07-20
Date terminated
2016-08-09
Location
Monroe, LA

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Related 510(k) clearances

RecordFirmDate
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) (K965059)Thomas Industries1997-03-04