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Terminated

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.

FDA Recall Z-0293-2007 · Posted 2007-01-09

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2005-10-06
Date Terminated2007-02-01
Product Quantity1

Reason for Recall

An incorrect serial number was placed on one roller pump.

Firm Action

The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.

Root Cause

Other

Distribution Pattern

Worldwide-Michigan and Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp. · 2003-03-20

Official Source

View FDA Recall →

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

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