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Terminated

Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09

FDA Recall Z-0601-06 · Posted 2006-03-09

Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeMEA
Date Initiated2005-11-02
Date Terminated2006-08-11
Product Quantity10,489 units

Reason for Recall

Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.

Firm Action

Field corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.

Root Cause

Other

Distribution Pattern

Nationwide. Distributed to 544 domestic consignees, all direct users.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043256HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03Hospira, Inc. · 2004-12-06K022203ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384Abbott Laboratories · 2002-08-01

Official Source

View FDA Recall →

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

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