Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
FDA Recall Z-3141-2024 · Posted 2024-09-13
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Recalling FirmCareFusion 303, Inc.
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-08-15
Product Quantity20145
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.
Firm Action
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: [email protected].
Email for receipt of customer response form and recall related questions -
Root Cause
Process control
Distribution Pattern
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, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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