Recall Z-0928-2023 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis MedBank System - Product Label/labeling pending
| Date | Jan 10, 2023 (initiated Dec 12, 2022) |
| Status | Open, Classified |
| Reason | Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm. |
| Root cause | Software design |
| Action | On 12/12/2022, the firm sent an "Urgent: Medical Device Correction" Letter via FedEx 2-Day mail to customers informing them of a software anomaly affecting BD Pyxis MedBank Cabinets with software version v.2.2 or prior. The firm was made aware that when using an atypical workflow the software would indicate that a different medication is loaded in a CUBIE pocket that what is physically loaded and listed on the CUBIE pocket label. This issue may occur when a new CUBIE is placed into an empty position that the software considers already occupied. Customer are instructed to: To mitigate and avo |
| Quantity | 6,796 systems |
| Distribution | U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.