BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1
Summary
The FDA issued a Class II for BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ by CareFusion 303, Inc.. Reason: Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical C.
Details
Source
Device Recall
External ID
Z-2256-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR MN 4FH-4HH-1FM MP/ 169-142, BD PYXIS MB TWR RXNOW MAIN W/MED PRINTER / 169-155, BD PYXIS MB TWR RXNOW MAIN W/PAT PRINTER/ 169-156, BD PYXIS MDBANK TWR MN 7HH-1HM-3FM/ 169-132, BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow/ 169-131, BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM/ 169-23, BD PYXIS MEDBANK TWR MN 10HH-2FH/ 169-24, BD PYXIS MEDBANK TWR MN 10HH-2FM/ 169-25, BD PYXIS MEDBANK TWR MN 12HH-1FF/ 169-26, BD PYXIS MEDBANK TWR MN 12HH-1FH/ 169-27, BD PYXIS MEDBANK TWR MN 12HH-1FM/ 169-28, BD PYXIS MEDBANK TWR MN 14HH/ 169-29, BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM/ 169-138, BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF/ 169-30, BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM/ 169-31, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/ 169-32, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/ 169-33, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/ 169-34, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/ 169-35, BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM/ 169-139, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/ 169-36, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/ 169-37, BD PYXIS MEDBANK TWR MN 2HH-6FM/ 169-38, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/ 169-39, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/ 169-40, BD PYXIS MEDBANK TWR MN 2HM-6FM/ 169-41, BD PYXIS MEDBANK TWR MN 3FH-4FM/ 169-42, BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS/ 169-140, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/ 169-43, BD PYXIS MEDBANK TWR MN 4HH-10HM/ 169-44, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/ 169-45, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/ 169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/ 169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/ 169-48, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/ 169-49, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/ 169-50, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/ 169-51, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/ 169-52, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/ 169-53, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/ 169-54, BD PYXIS MEDBANK TWR MN 4HH-5FH / 169-55, BD PYXIS MEDBANK TWR MN 4HH-5FM/ 169-56, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/ 169-57, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/ 169-58, BD PYXIS MEDBANK TWR MN 4HM-5FM/ 169-59, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/ 169-60, BD PYXIS MEDBANK TWR MN 5HH-9HM/ 169-61, BD PYXIS MEDBANK TWR MN 6FH-1FM/ 169-62, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/ 169-63, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/ 169-64, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/ 169-65, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/ 169-66, BD PYXIS MEDBANK TWR MN 6HH-4FH / 169-67, BD PYXIS MEDBANK TWR MN 6HH-4FM/ 169-68, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/ 169-69, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/ 169-70, BD PYXIS MEDBANK TWR MN 6HH-8HM/ 169-71, BD PYXIS MEDBANK TWR MN 7FH/ 169-72, BD PYXIS MEDBANK TWR MN 7FM/ 169-73, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/ 169-74, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/ 169-75, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/ 169-76, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/ 169-77, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/ 169-78, BD PYXIS MEDBANK TWR MN 8HH-3FF/ 169-79, BD PYXIS MEDBANK TWR MN 8HH-3FH/ 169-80, BD PYXIS MEDBANK TWR MN 8HH-3FM/ 169-81, BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P/ 169-82, BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P/ 169-83, BD PYXIS MEDBANK TWR MN CR-12HH-1FH/ 169-84, BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P/ 169-85, BD PYXIS MEDBANK TWR MN CR-14HH-P/ 169-86, BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM/ 169-87, BD PYXIS MEDBANK TWR MN CR-2HH-6FH/ 169-88, BD PYXIS MEDBANK TWR MN CR-2HH-6FM/ 169-89, BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P/ 169-90, BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P/ 169-91, BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P/ 169-92, BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P/ 169-93, BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P/ 169-94, BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P/ 169-95, BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P/ 169-96, BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P/ 169-97, BD
Lot/Code Info: UDI-DI: 10885403512568. Devices Manufactured November 15, 2012 - July, 25 2023 User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.
Quantity Affected: 3002
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-13
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2256-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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