Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2149-2015Class II

THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240

Gardner Denver Thomas Inc / initiated 2015-06-04 / Terminated / root cause: manufacturing process

Gardner Denver Thomas Inc began a recall of THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator on . FDA classified it as Class II and gives the reason as "Vacuum pump may not perform to specification". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2149-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Gardner Denver Thomas Inc
Product
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall
Vacuum pump may not perform to specification.
Root cause tag
manufacturing process
FDA root 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
160 units
Distribution
Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
Product codes and lots
Serial Numbers 2639-2798

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2149-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2149-2015Class IITerminatedVoluntary: Firm initiated
Z-2150-2015Class IITerminatedVoluntary: Firm initiated
Z-2151-2015Class IITerminatedVoluntary: Firm initiated