U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8

FDA device recall Z-1710-2008 · posted 2008-06-10 · Terminated

Recall details

Recalling firm

Cardinal Health 303 Inc DBA Alaris Products

Reason for recall

A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump module ("Pump module"). The user will be required to replace the affected module.

Action taken

An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

85,286 units

Distribution

Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN,

Date initiated

2008-03-05

Date posted

2008-06-10

Date terminated

2011-09-13

Location

San Diego, CA

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