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Terminated

Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

FDA Recall Z-0147-2010 · Posted 2009-11-09

Recalling FirmHospira Inc
Recall StatusTerminated
Product Codedxg
Date Initiated2009-08-11
Date Terminated2012-04-04
Product Quantity204,999 power cords distributed for all devices

Reason for Recall

Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.

Firm Action

Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932414CONTINUOUS CARDIAC OUTPUT SYSTEMAbbott Laboratories · 1994-11-14

Official Source

View FDA Recall →

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

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