Recall Z-2151-2015

Gardner Denver Thomas Inc · initiated June 4, 2015

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator

Codes / lots: Serial numbers 2122-2629

Reason for recall

Vacuum pump may not perform to specification.

FDA-determined cause: Nonconforming Material/Component

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.

Details

Recall number
Z-2151-2015
Initiated
June 4, 2015
Posted by FDA
July 20, 2015
Terminated
August 9, 2016
Product code
JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
Quantity
508 units
Distribution
Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
Recalling firm
Gardner Denver Thomas Inc, Monroe, LA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2149-2015 Class IITHOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical…Vacuum pump may not perform to specification. 06/04/2015Terminated
Z-2150-2015 Class IITHOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical…Vacuum pump may not perform to specification. 06/04/2015Terminated