Z-2939-2020Class I

BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N...

Name: Z-2939-2020 BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N...
Creator: CareFusion 303, Inc.
Published: 2020-08-04
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-08-04 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump on 2020-08-04. FDA classified it as Class I and gives the reason as "Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2939-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-08-04
Posted: 2020-09-12
Recalling firm: CareFusion 303, Inc
Product: BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Product code: FRN Pump, Infusion
Reason for recall: Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
Root cause tag: design
FDA root cause: Device Design
Action: On August 4, 2020, the firm notified affected customers via mail, "Urgent Medical Device Recall", indicating the following: Actions for Clinical Users: Clinicians should remove the pump from service and send to Biomedical Engineering if the Pump Module keypad becomes unresponsive or stuck. If a critical medication is being administered, continue the infusion until it is safe to replace the Pump Module. In an urgent situation, clinicians can close the roller clamp on the IV administration set to stop an infusion. Actions for Cleaning Personnel: Follow the cleaning instructions provided in the current Directions for Use to minimize the potential for fluid ingress during cleaning. - Do not use a cloth that drips. Be sure to wring out the cleaning cloth to squeeze out excess fluid. - Do not spray fluids directly onto the device. Actions for Biomedical Engineering: Inspect all uninstalled Pump Module Door Assembly Replacement Kits noted above. All kits dated prior to January 25, 2019 are affected. If affected kits are found upon inspection, dispose per facility guidelines. An example of how to identify the date on the keypad is provided below: - Contact BD at 1-800-482-4822 to order replacement Pump Module keypad kits at no charge (either discarded by your facility or needed for remediation of the Pump Module), - Contact the BD Recall Support Center at 1-888-562-6018 to schedule remediation of the pump module at no charge if unable to perform at your location. - Maintain a list of all Pump Module serial numbers remediated to provide to BD upon completion of the activity. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and the recall instructions provided in this letter. Actions for BD Alaris System rental providers: Provide a copy of this letter to your customers who are currently renting BD Alaris System devices. Actions by BD: BD redesigned and implemented the Alaris Pump Mo
Quantity in commerce: 248,519
Distribution: Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY); United Arab Emirates (AE); Australia (AU); Canada (CA); Hungary (HU); Israel (IL); Japan (JP)* Kuwait (KW); New Zealand (NZ); Philippines (PH); Qatar (QA); Saudi Arabia (SA); Singapore (SG); Taiwan (TW); Turkey (TR)*. *There are 159 U.S. government and/or military consignees including two located in Japan (JP) and Turkey (TR).
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2939-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2939-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-09-16	2020-09-10

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)