—#211846

Product

BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: UDI: 10885403512636/ Serial Numbers: 16187325, 16187326, 16187327, 16173446

Why it was recalled

Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.

Root cause (FDA determination)

Device Design

Action the firm took

On February 14, 2023 and January 9. 2024 Carefusion issued a Urgent medical Device Product Advisory" Recall Notification to affected consignees. Carefusion asked consignees take the following actions: 1. Customers may continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800-727-6102, should you experience drawer or door failures. 2. If you experience delays in access to medication due to a drawer or door failure, ensure backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. 4. If you have specific questions about this letter, please contact 1-866-583-8783. 5. Any adverse health consequences experienced with the use of this product should be reported to BD and may be reported to the FDA s MedWatch Adverse Event Reporting Actions to be taken by distributor 1. Please provide a copy of this notification to any customers who may have received products listed in the Affected Products table above. 2. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM

Timeline

Recall initiated: 2024-02-23
Posted by FDA: 2025-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211846. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.