Company:Cardinal Health
Date of Enforcement Report 5/6/2009
Class:ll

PRODUCT
Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Recall # Z-1237-2009

REASON
The Alaris PCA module can potentially infuse above or below the intended infusion dose.

RECALLING FIRM/MANUFACTURER
Cardinal Health 303 dba Cardinal Health, San Diego, CA, by letter on March 11, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
164,000 units

DISTRIBUTION
Nationwide, Canada, Germany, Malaysia, and Singapore