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Terminated

THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator

FDA Recall Z-2150-2015 · Posted 2015-07-20

Recall StatusTerminated
Product CodeJCX
Date Initiated2015-06-04
Date Terminated2016-08-09
Product Quantity370 units

Reason for Recall

Vacuum pump may not perform to specification.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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