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Terminated

Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank

FDA Recall Z-0158-2007 · Posted 2006-11-07

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeDTQ
Date Initiated2006-09-01
Date Terminated2007-12-19
Product Quantity132 or less in US. Firm officials stated that 66 base units in US 8/1/05 to 8/14/06 - each units comes with 2 hand cranks.

Reason for Recall

The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

Firm Action

The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.

Root Cause

Other

Distribution Pattern

worldwide

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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