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Terminated

Jostra HL-20 Heart Lung Machine - guiding pins

FDA Recall Z-0159-2007 · Posted 2006-11-07

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeDTQ
Date Initiated2006-10-03
Date Terminated2007-12-19
Product Quantity227 HL-20 base units with 545 single pumps

Reason for Recall

The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.

Firm Action

An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx 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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