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Terminated

Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.

FDA Recall Z-1394-2011 · Posted 2011-02-22

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDTQ
Date Initiated2010-09-28
Date Terminated2011-08-11
Product Quantity4 units

Reason for Recall

A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.

Firm Action

Maquet hand delivered a letter to the consignee on 10/4/2010.

Root Cause

Component change control

Distribution Pattern

One hospital in New York City

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943803JOSTRA HL-20 INTEGRATED PERFUSION SYSTEMJanus Biomedical, Inc. · 1996-01-30

Official Source

View FDA Recall →

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

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