Device recall: THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
FDA enforcement event 71569 is a device recall by Gardner Denver Thomas Inc of Monroe, LA, initiated 4 Jun 2015 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 9 Aug 2016. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Gardner Denver Thomas Inc.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gardner Denver Thomas Inc, Monroe, LA.
Reason for recall
"Vacuum pump may not perform to specification."
Distribution
"Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2149-2015 | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator | 160 units | Class II | Terminated | 29 Jul 2015 |
| Z-2150-2015 | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator | 370 units | Class II | Terminated | 29 Jul 2015 |
| Z-2151-2015 | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator | 508 units | Class II | Terminated | 29 Jul 2015 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Vacuum pump may not perform to specification."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.