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Terminated

Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

FDA Recall Z-0078-2008 · Posted 2007-10-31

Recalling FirmGambro BCT, Inc.
Recall StatusTerminated
Product CodeLKN
Date Initiated2007-09-18
Date Terminated2008-01-25
Product Quantity15 units

Reason for Recall

Under specific conditions, apheresis machine could return up to 60mL of air to the patient.

Firm Action

All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.

Root Cause

Software design

Distribution Pattern

US, Canada, Australia, Europe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071079SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200Gambro Bct, Inc. · 2007-08-02

Official Source

View FDA Recall →

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

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