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Health product recall

LifeCare PCA Plus II and LifeCare PCA 3 Infusion System

Starting date:
August 21, 2012
Posting date:
September 17, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices, Product Safety
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15540

Recalled Products

A. LifeCare PCA Plus II

B. Système de perfusion LifeCare PCA 3

Reason

Improper use of the slide clamp when the syringe (Vial) was manipulated where the clamp should have been closed. These use errors resulted in over delivery of narcotic medications which has the potential to cause critical injury to the patient.

Affected products

A. LifeCare PCA Plus II

Lot or serial number

All Serial Numbers

Model or catalog number

1950

Companies
Manufacturer

Hospira Inc.



B. LifeCare PCA 3 Infusion System

Lot or serial number

All Serial Numbers

Model or catalog number

12384, 20709

Companies
Manufacturer

Hospira Inc.