Z-2151-2015Class II

THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243

Name: Z-2151-2015 THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243
Creator: Gardner Denver Thomas Inc
Published: 2015-06-04
License: https://open.fda.gov/license/

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

FDA source

Gardner Denver Thomas Inc began a recall of THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator on 2015-06-04. FDA classified it as Class II and gives the reason as "Vacuum pump may not perform to specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2151-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-07-20
Terminated: 2016-08-09
Recalling firm: Gardner Denver Thomas Inc
Product: THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 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: 508 units
Distribution: Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
Product codes and lots: Serial numbers 2122-2629

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2151-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2149-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2150-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2151-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code JCX

K965059Class IICpi, Maxi-Vac(6480),thomas Industries, Medi-Pump(1240/1242/1243)Thomas Industries / cleared 1997-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)