Class 2 Device Recall Alaris Medley 8000,8100, 8110,8120,8210 and, 8220

• Date Initiated by Firm: March 05, 2008
• Date Posted: June 10, 2008
• Recall Status: Terminated on September 13, 2011
• Recall Number: Z-1711-2008
• Recall Event ID: 47335
• 510(K)Number: K950419 K012383 K023264 K043299 K022677 K010966
• Product Classification: Infusion Pump - Product Code FRN
• Product: Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit),; (2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module),; (3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module),; (4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module), ; (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and; (6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology, CardinalHealth, San Diego, CA 92130
• Code Information: Pending
• Recalling Firm/ Manufacturer: Cardinal Health 303 Inc DBA Alaris Products; 10221 Wateridge Cir; San Diego CA 92121-2733
• For Additional Information Contact: Cardinal Health Recall Center; 800-625-6627
• Manufacturer 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 with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March
• FDA Determined Cause: Device Design
• 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 include Required 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.
• Quantity in Commerce: 77,515 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, 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. ****
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.; 510(K)s with Product Code = FRN and Original Applicant = IMED CORP.