Z-1309-2021Class I

BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit...

Name: Z-1309-2021 BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit...
Creator: CareFusion 303, Inc.
Published: 2021-03-03
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2021-03-03 / Open, Classified / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346... on 2021-03-03. FDA classified it as Class I and gives the reason as "Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1309-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-03-03
Posted: 2021-04-01
Recalling firm: CareFusion 303, Inc
Product: BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Product code: FRN Pump, Infusion
Reason for recall: Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 03/03/2021, Medical Device Recall notices were mailed to customers including, Directors of Biomedical Engineering, Directors of Nursing, and Directors of Risk Management. Customers were asked to return the customer response form and were advised of the following: If you had previously remediated devices affected by the August 4, 2020 Pump Module Keypad Recall, those devices will not need to be remediated a second time, as a result of this recall. If Pump Module keypad lifting or stuck or unresponsive keys are observed, remove the pump from service and send to Biomedical Engineering. 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. Follow 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. All affected Pump Module Door Assembly Replacement Kits should be disposed per facility guidelines. Contact 1-800-482-4822 to order replacements. A list of affected pump module and pump module keypad serial numbers are posted on or bd.com/mms-21-3991 Select one of the remediation options below: 1): Order replacement Pump Module keypad kits at no charge and repair the devices internally. Contact 1-800-482-4822. After replacement, safely destroy all affected parts. 2): Ship devices back for repair at no charge, Contact Support Center at 1-888-562-6018. 3) Schedule remediation of the affected devices at your facility, contact 1-888-562-6018. A service technician will visit your facility and perform keypad replacements of affected devices at no charge. The root cause was identified as a supplier manufacturing process issue and has been resolved.
Quantity in commerce: 160300
Distribution: Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ
Product codes and lots: Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1309-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1309-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-04-01

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)