Recall Z-1229-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS
| Date | Feb 21, 2025 (initiated Jan 8, 2025) |
| Status | Open, Classified |
| Reason | Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. |
| Root cause | Under Investigation by firm |
| Action | On January 8, 2025, CareFusion 303 issued a "Urgent: Medical Device Correction" Notification to affected customer via mail or Email. CareFusion asked consignees to take the following actions: 1. Customers should immediately ensure that MedBank" devices are not installed in the procedural or operating space and at least 1.5 meters from patients. 2. Report any issues associated with the above products to BD Pyxis" MedBank" Product Support Line via phone at 866-930-9251. 3. Report any adverse health consequences experienced with the use of this product to the FDA's MedWatch Adverse Event Rep |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.