139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2

FDA device recall Z-1229-2025 · posted 2025-02-21 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Action taken

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

Status

Open, Classified

Product code

BRY

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

Date initiated

2025-01-08

Date posted

2025-02-21

Location

San Diego, CA