Z-1711-2008

Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March...

Name: Z-1711-2008 Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March...
Creator: Cardinal Health 303 Inc DBA Alaris Products
Published: 2008-03-05
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2008-03-05 / Terminated / root cause: design

FDA source

Cardinal Health 303 Inc DBA Alaris Products began a recall of 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... on 2008-03-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1711-2008
Status: Terminated
Initiated: 2008-03-05
Posted: 2008-06-10
Terminated: 2011-09-13
Recalling firm: CareFusion 303, Inc
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
Product code: FRN Pump, Infusion
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
Root cause tag: design
FDA root 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 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.
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. ****
Product codes and lots: Pending

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)