Recall Z-1207-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
| Date | Feb 21, 2025 (initiated Jan 23, 2025) |
| Status | Open, Classified |
| Reason | Due to fingerprint scanner failing resulting in the scanner heating up. |
| Root cause | Nonconforming Material/Component |
| Action | On 1/23/2025, the firm sent a "Urgent Medical Device Correction" Letter via FedEx and email to customers informing them that the firm became aware via customer complaints that an internal component within the Bio-ID (fingerprint scanner) is failing and resulting in the Bio-ID scanner heating up and could potentially cause superficial burns if finger is left on the scanner for up to or more than 5 seconds. Customers are instructed: 1. BD Pyxis" SupplyStation" and MedFlex 2.0 can continue to be used as intended. If you suspect that the Bio-ID Scanner is hot, please discontinue the use of the Bi |
| Quantity | 229 MedFlex and 3,154 spare Bio-ID spare parts |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AL, 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, and WY. The countries of Australia, Bahrain, Belgium, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.