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BD Alaris Pump Module REF 8100 recallZ-1231-2025 · CareFusion 303, Inc. · initiated Jan 23, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

FDA root cause category: Under Investigation by firm

What the company is doing

On 01/23/2025, the firm sent via FedEx, 2-day mail and email an "URGENT MEDICAL DEVICE LABELING CORRECTION" Letter to customers informing them that Through an internal review, BD has identified that in the BD Alaris" System User Manual v 12.3.1 (p/n #P00000455), 12.3.2 (p/n# P00000827) and 12.4 (p/n# P00000828), there is an incorrect note on the Pump Module Set Loading instructions. The manuals incorrectly instruct users to leave the safety clamp in the open position when reloading an infusion set. The correct procedure is to leave the safety clamp in the closed position. Following the incorrect note could potentially disable a safety feature that could result in an accidental over-infusion if the roller clamp is left open. Customers are instructed to: 1. Post the Customer Notification on or near the affected systems as a reminder of the incorrect labeling issue until the Manual/Directions for Use (DFU) have been corrected. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form within 14 days, so that BD may acknowledge your receipt of this notification per FDA requirements and prioritize remediation scheduling. Actions BD is taking: 1. BD is in the process of updating the impacted user manuals. 2. BD will send customers follow-up notifications once the update of user manuals is completed. BD expects an updated user manual to be available by April 2025. For Questions or assistance: Contact - North American Regional Complaint Center for Product Complaints and Technical Questions at: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted. Mon Fri 8:00am and 5:00pm CT or Email: [email protected] Contact Post Market Quality for Recall Questions at: Email : [email protected] Fax No.: 312-949-0576

Recall details

Recall number
Z-1231-2025
Status
Open, Classified
Initiated by the company
Jan 23, 2025
Posted by the FDA
Feb 24, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
242,098 systems
Product code
FRN
FDA submissions
K211218
Distribution
U.S.: 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, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba O.U.S.: Canada

Product description

BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration

Code information (models, lots, serial numbers)

Catalog Number: 8100 UDI-DI codes: 10885403810046 10885403517723 Software Version: 12.1.2 Serial/Lot Numbers: Pending

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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