—#208105

Product

BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK MINI 2HH-1FM MEDPASS/ 169-152, MEDBANK MINI 2HH-2HM/ 169-108, MEDBANK MINI 2HM-1FM/ 169-109, MEDBANK MINI 3HH-1FG/ 169-110, MEDBANK MINI 3HH-1HM/ 169-111, MEDBANK MINI 4HH/ 169-112, MEDBANK MINI 4HH MEDPASS/ 169-150, MEDBANK MINI 4HM/ 169-113, MEDBANK MINI CR-2HH-1FH-P/ 169-114, MEDBANK MINI CR-4HH-P/ 169-115, MB MINI MAIN CR/ 169-163, MB MINI MAIN W/CUBIE DRWS/ 169-159, MB MINI MAIN W/FH FALSE DRW/ 169-162, MB MINI MAIN W/HH FALSE DRW/ 169-161, MB MINI MAIN W/MATRIX DRWS / 169-160, MB MINI MAIN W/MP/ 169-164 Used with the following user guides: BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989), BD Pyxis MedBank Cabinet User Guide (DIR 10000414987), BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: UDI-DI: 10885403512544. Devices Manufactured November 15, 2012 - July, 25 2023 User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.

Why it was recalled

Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.

Root cause (FDA determination)

Component design/selection

Action the firm took

On 5/13/24, correction notices were mailed and emailed to customers informing them of the following: 1) Beginning, July 21, 2023, the firm ceased providing devices with MSO Power Strips and began providing devices with Uninterrupted Power Supply (UPS). 2) Firm will be providing impacted customers with UPS replacement devices for MSO Power Strips. Firm will be issuing a follow-up communication in the upcoming weeks with additional details regarding UPS replacement devices. 3) Firm will be updating user guides to clarify against the use of MSO Power Strips with affected devices. User guides can be obtained in the Customer Self Service Portal. 4) Customers should discard CyberPower Surge Protector Multiple Socket-Outlet MSO Power Strips, PN 15001-01 at their site AFTER receipt and installation of their UPS replacement device. 5) continue to follow general electrical safety practices including: -Always power off the station and unplug from the wall prior to any servicing. -Always select an unused wall outlet for the MSO/UPS connection. -Always connect this equipment to a supply mains with protective earth. 6) If power is lost to the device resulting in a downtime scenario, keys may be used to manually access contents within the device. 7) Please disseminate this notification within your distribution or facility network 8) Complete and return the response form to BDRC47@bd.com -Distributors are asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the included customer letter to all customers to advise them of this field action notification. Further assistance, please contact: Technical Support call: 1-866-930-9251, 24 hours, 7 days a week. Regional Complaint Center: 1-844-823-5433 Say "Product Complaints" when prompted. Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com. Post Market Quality Field Action Operations: Email: BDRC47@bd.com

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS, IL, FL, OK, OH, TN, GA, NM, NV, NE, TX, NC, KY, WI, SC, IA, MT, SD, VA, NJ, PA, AK, MS, MI, WA, UT, ND, MA, MN, OR, IN, WV, AL, ID, LA, CT, WY, MD, NH, AR, HI, DC.

Timeline

Recall initiated: 2024-05-13
Posted by FDA: 2024-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208105. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.