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BD Pyxis recallZ-2490-2024 · CareFusion 303, Inc. · initiated Jun 24, 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

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDA root cause category: Under Investigation by firm

What the company is doing

On July 11, 2024, CareFusion, subsidiary of Becton, Dickinson and Company (BD) issued a "Urgent Medical Device Correction" Notification, via mail. On June 24, 2024, BD issued Customer Release Notes via their firm's customer portal. BD ask consignees to take the following actions: Clinicians: 1. When restocking the cabinet, refer to the MedBank restock workflow screen to verify the correct bin location rather than the printed label until the software update is provided. Users should verify the contents of the bin location being restocked. 2. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedBank" CUBIE" Replenishment Station devices to. 3. Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter Distributor: 1. Please provide a copy of the attached customer letter to all facilities within your distribution network that have any product listed in Appendix 1. 2. Please promptly complete and return the enclosed Distributor Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter.

Recall details

Recall number
Z-2490-2024
Status
Open, Classified
Initiated by the company
Jun 24, 2024
Posted by the FDA
Aug 2, 2024
Recalling firm
CareFusion 303, Inc.
Quantity
7 units
Product code
BRY
Distribution
US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.

Product description

BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9

Code information (models, lots, serial numbers)

UDI: 10885403512568/ Serial Number: 16167616 16188929 15941657 15941700 15941694 15922822 15941698

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 94947).

Sources and updates

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