Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alari

FDA device recall Z-0460-2008 · posted 2008-01-04 · Terminated

Recall details

Recalling firm

Cardinal Health 303 Inc DBA Alaris Products

Reason for recall

Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly

Action taken

The field notification (Urgent Medical Device Recall Letter) will consist of a mailing conducted through consignees (distributors in the affected countries as well as direct customers for the Alaris Pump module (a.k.a. Medley Pump module). The domestic letters are expected to be mailed on November 5, 2007 to all of the affected accounts by return receipt mailing. A Customer Response Card will be mailed with each letter along with a Service Bulletin detailing the protocol to conduct the Occluder Pressure Test. Four (4) letters will be mailed to each account to the following titles/job functions: Director of Nursing, Director of Biomed, Director of Materials Management, and Director of Risk Management. Distributors will be sent multiple copies of the Recall Notification, Customer Response Cards, and Service Bulletin, along with a cover letter outlining their responsibilities to complete the Recall notification plan and notify their customers as requested. The letters will be the first source of communication regarding this issue. The Recall Center will be contacting customers shortly to make arrangements for inspection of the devices at the users site. The international mailings are being coordinated out of the offices located in the affected countries. The letter will be translated to the appropriate language and mailed to all of the affected customers. The appropriate international regulatory authorities will be notified of this issue, and will work with the country managers.---------A web site for all information on this recall is listed as: www.cardinalhealth.com/alaris/indexmodulealert.asp ****************** January 23, 2008 the firm notified the Los Angeles Districe that they will be sending a recall notification update to 267 customers and distributors who are affected by this 806 Notification Amendment. Cardinal Health intends to notify these consignees by mail on January 30, 2008. This update will affect a total of 267 customers, 5,681 units and 798

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

207,257 units

Distribution

Worldwide: USA including the following forty-six (46) states, along with Washington, D.C. Puerto Rico and Guam: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia,

Date initiated

2007-10-29

Date posted

2008-01-04

Date terminated

2011-06-06

Location

San Diego, CA