Z-2910-2020Class I

PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY...

Name: Z-2910-2020 PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY...
Creator: CareFusion 303, Inc.
Published: 2020-08-04
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-08-04 / Open, Classified

FDA source

CareFusion 303, Inc. began a recall of PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR... on 2020-08-04. FDA classified it as Class I and gives the reason as "The 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, interruption of infusion, or inability to titrate...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2910-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-08-04
Posted: 2020-09-04
Recalling firm: CareFusion 303, Inc
Product: PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
Product code: FRN Pump, Infusion
Reason for recall: The 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, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
FDA root cause: Reprocessing Controls
Action: On 08/04/20, Urgent Medical Device Recall notices were mailed to Clinical Users: If the PC unit keypad becomes unresponsive or a key gets stuck, clinicians should remove the device from service and send to Biomedical Engineering. If administering a critical medication, continue the infusion until it is safe to replace the PC unit. Cleaning personnel can minimize the potential for fluid ingress during cleaning by 1) not using a cloth that drips, 2) wringing out the cleaning cloth to squeeze out excess fluid, and 3) not spraying fluids directly onto the device. Biomedical Engineering: If an affected PC unit has an unresponsive keypad or stuck key, remove the unit from service and call the recalling firm for information replacement parts. Until 510(k) clearance, the affected PC unit keypad design will continue to be provided for replacement or repair. Inspect all PC unit keypads for bubbling, cracks, damage, layer separations, and holes. Replace the front case keypad if it fails inspection. Return the completed Customer Response Form. Provide a copy of this letter and enclosures to customers who are currently renting affected devices. Firm is currently working on a design change for the PC unit keypad and will notify customers when replacement keypads are available. Additional Information: Customer Advocacy, 888-812-3266, [email protected]; Training Resources www.bd.com/alaris-system-hardware-recall; Recall Support Center, 888-562-6018, [email protected]; Technical Support, 888-812-3229, [email protected]; Customer Order Management, 1-800-482-4822, [email protected] On 12/16/22, Medical Device Notifications were sent to customers informing them that they may have received impacted parts for repair purposes or received product with impacted parts. Customers were provided with links to the original recall notices and asked to review the information and complete the customer response form.
Quantity in commerce: 28346
Distribution: U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA
Product codes and lots: All kits manufactured from April 07, 2017 to Present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2910-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2909-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-09-16	2020-09-04
Z-2910-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-09-16	2020-09-04

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)