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Terminated

U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA 92130

FDA Recall Z-1712-2008 · Posted 2008-06-10

Recalling FirmCardinal Health 303 Inc DBA Alaris Products
Recall StatusTerminated
Product CodeFRN
Date Initiated2008-03-05
Date Terminated2011-09-13
Product Quantity8,286 units

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 failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to re

Firm Action

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

Distribution Pattern

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, TX, UT, VA, VT, WA, WI and WY, Guam and country of Canada. ****CDRH Comments: "Note for District Office to follow-up" The firm has not provided a grand total of devices affected by these problems. It is possible that devices suffering from U19 & U9 problems may also experience IUI problems. This recall has 3 problems with 6 modules. One problem affects only 2 modules, one problem affects 6 modules. For simplicity and expediency, CDRH agrees to keep the file as is, rather than separate into 6 products and have complicated explanations of the problems. 77,515 devices affected by IUI problem. 85,286 devices affected by U19 problem. 8,286 devices affected by U9 problem. ****

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043299MEDLEY PCA MODULE, MODEL 8120Alaris Medical Systems, Inc. · 2004-12-10K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110Alaris Medical Systems, Inc. · 2002-12-19K022677MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLEAlaris Medical Systems, Inc. · 2002-09-11K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT CAlaris Medical Systems, Inc. · 2001-10-02K010966MEDLEY SP02 MODULE, MODEL 8220Alaris Medical Systems, Inc. · 2001-06-08K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSImed Corp. · 1995-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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