139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
FDA Recall Z-1230-2025 · Posted 2025-02-21
Recalling FirmCareFusion 303, Inc.
Recall StatusOpen, Classified
Product CodeBRY
Date Initiated2025-01-08
Reason for Recall
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
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 Reporting program.
4. Please post these notices with the device until labeling has been updated.
5. Complete the attached Customer Response Form and return to BD.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.