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Device Recall Alaris PCA Module and Alaris PC Unit with software versions 8 thourh 9.1
Model / Serial
software versions 8 through 9.1. Serial Numbers: 000000000003692805, 000000000002326369 to 000000000012892953.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Germany, Malaysia, and Singapore.
Product Description
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.
Manufacturer
Cardinal Health 303 dba Cardinal Health
1 Event
Recall of Device Recall Alaris PCA Module and Alaris PC Unit with software versions 8 thourh 9.1
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Manufacturer
Cardinal Health 303 dba Cardinal Health
Manufacturer Address
Cardinal Health 303 dba Cardinal Health, 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
Manufacturer Parent Company (2017)
Cardinal Health
Source
USFDA
Language
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