U19 Socketed Integrated Circuit ("U19 IC") on the logic… recallZ-1710-2008 · Cardinal Health 303 Inc DBA Alaris Products · initiated Mar 5, 2008

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number

Z-1710-2008

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Mar 5, 2008

Posted by the FDA

Jun 10, 2008

Recalling firm

Cardinal Health 303 Inc DBA Alaris Products

Quantity

85,286 units

Product code

FRN

FDA submissions

K012383, K950419

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. ****

Product description

U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130

Other devices under the same FDA submission

1 device cleared under K012383, K950419 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Alaris 8100

  Carefusion 303, Inc. · Pump, infusion
  2 recalls2 deaths650,218 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 47335).

• Z-1711-2008 · Terminated
  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)* (…
• Z-1712-2008 · 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…