| | Class 2 Device Recall |  |
| Date Initiated by Firm | May 13, 2024 |
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| Date Posted | July 02, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2256-2024 |
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| Recall Event ID |
94720 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| Product | 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 |
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| Code Information |
UDI-DI: 10885403512568. Devices Manufactured November 15, 2012 - July, 25 2023
User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.
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| FEI Number |
2016493
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Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
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| For Additional Information Contact |
888-876-7128 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Component design/selection |
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| Action | 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 |
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| Quantity in Commerce | 3002 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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