Recall Z-1206-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
| Date | Feb 21, 2025 (initiated Jan 10, 2025) |
| Status | Open, Classified |
| Reason | Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions. |
| Root cause | Labeling design |
| Action | On 1/10/2025, correction notices were mailed or emailed to Directors of Nursing or Nurse Managers, Directors of Pharmacy or Pharmacist In Charge, and Facility Administrators informing them to take the following actions: Customers should do the following to prevent delays in access: a. Ensure staff are aware of updates to User Guides, including: automated dispensing devices should not be used as a crash cart or code box. Medication or items may not be immediately accessible for an emergent situation causing a delay in treatment which could lead to serious injury or death. b. Have device keys |
| Quantity | 1521 |
| Distribution | US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.