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Open, Classified

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.

FDA Recall Z-1207-2025 · Posted 2025-02-21

Recalling FirmCareFusion 303, Inc.
Recall StatusOpen, Classified
Product CodeBRY
Date Initiated2025-01-23
Product Quantity229 MedFlex and 3,154 spare Bio-ID spare parts

Reason for Recall

Due to fingerprint scanner failing resulting in the scanner heating up.

Firm 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 Bio-ID Scanner, submit a complaint to BD, and use your username and password to login instead. 2. Please return the customer response form to acknowledge receipt of this notice. For questions/assistance: -Technical Support - Phone: 1-866-930-9251 Phone hours: 24 hours, 7 days a week for Technical Questions. -Regional Complaint Center - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted. Mon-Fri 8:00am-5:00pm CT or Email: [email protected] for Product Complaints -Field action related questions - Email (pending) - Email for receipt of customer response forms and recall related questions.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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, Brazil, Canada, Hong Kong, Kuwait, Lebanon, New Zealand, Qatar, Saudi Arabia, Spain, and Thailand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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