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BD Pyxis recallZ-2255-2024 · CareFusion 303, Inc. · initiated May 13, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Component design/selection

What the company is doing

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 [email protected] -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: [email protected]. Post Market Quality Field Action Operations: Email: [email protected]

Recall details

Recall number
Z-2255-2024
Status
Open, Classified
Initiated by the company
May 13, 2024
Posted by the FDA
Jul 2, 2024
Recalling firm
CareFusion 303, Inc.
Quantity
677
Product code
BRY
Distribution
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.

Product description

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)

Code information (models, lots, serial numbers)

UDI-DI: 10885403512544. Devices Manufactured November 15, 2012 - July, 25 2023 User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94720).

Sources and updates

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