Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

FDA device recall Z-3141-2024 · posted 2024-09-13 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

Action taken

On 08/15/2024, the firm sent an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" Letter via FedEx /2-day or email to customers informing them that, BD has identified an increase in bent contacts on the new Female/Left IUI connectors which may cause delays in initiating therapy. Customer are instructed to: 1. Per current labeling, customers should inspect all IUI connectors prior to use. You may also refer to Appendix A for further details. 2. If you identify a bent/lifted IUI pin prior to use, do not use the device and send the device to biomedical engineering or Qualified Service Personnel for repair. 3. Please distribute this notice to all facility personnel responsible for inspection of BD Alaris" devices. For questions/assistance - Technical Questions - Technical Support - Phone: 1-866-488-1408, Phone hours: 5:00am to 5:00pm PT, Monday Friday. Product Complaints - BD Designated Complaint Handling Unit - Phone: 1-888-812-3266 Phone hours: 7:00am to 5:00pm PT, Monday Friday, Email: productcomplaints@bd.com. Email for receipt of customer response form and recall related questions -

Root cause

Process control

Status

Open, Classified

Product code

FRN

Quantity affected

20145

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ

Date initiated

2024-08-15

Date posted

2024-09-13

Location

San Diego, CA

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