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Class 2 Device Recall BD Pyxis

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Class 2 Device Recall BD Pyxis

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Date Initiated by Firm	January 23, 2025
Date Posted	February 21, 2025
Recall Status¹	Open³, Classified
Recall Number	Z-1207-2025
Recall Event ID	96004
Product Classification	Cabinet, table and tray, anesthesia - Product Code BRY
Product	BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
Code Information	BD Pyxis MedFlex 2.0 Catalog Number: 1139-00 UDI-DI code: 10885403512704 Serial/Lot Numbers: 16188677 16234871 16234918 16234919 16234920 16235771 16235773 16235774 16235776 16235777 16235778 16235779 16235780 16237465 16237466 16237807 16237809 16237810 16237811 16237812 16237813 16238647 16245711 16245712 16245713 16245718 16248197 16248200 16248203 16248207 16248208 16248209 16248211 16248214 16248216 16248217 16249389 16249390 16249392 16249393 16249394 16249395 16253258 16253259 16253260 16253261 16253264 16253421 16253423 16255087 16255088 16255089 16255090 16255091 16255092 16255093 16255094 16255648 16255649 16255650 16255651 16255652 16257751 16257779 16257780 16257782 16257783 16257784 16258336 16258339 16258341 16259235 16262553 16263864 16263866 16271070 16271697 16273523 16273525 16274621 16274623 16285712 16285719 16290130 16290131 16294039 16294040 16297183 16297187 16301869 16301974 16306024 16314884 16319674 16323805 16323807 16324856 16324858 16324880 16324881 16324882 16324883 16329840 16329841 16329842 16329843 16329844 16329845 16331234 16331235 16331237 16331239 16331241 16331243 16331371 16331372 16331373 16331374 16331376 16331473 16331474 16331475 16331476 16331477 16335406 16335407 16335408 16335925 16335926 16337394 16354646 16354647 16354648 16356143 16356144 16356145 16360888 16372466 16373119 16375388 16387858 16387868 16395522 16395523 16395524 16395525 16395527 16397522 16399720 16399721 16399723 16399725 16406085 16410148 16412199 16412200 16412201 16412202 16412203 16412204 16413409 16413413 16413414 16413415 16413416 16413417 16413418 16413419 16413420 16413421 16416112 16416513 16416514 16416515 16416516 16416517 16416521 16416522 16416523 16416524 16416525 16423188 16423191 16423192 16423194 16423195 16445044 16445048 16445052 16445058 16446397 16450291 16455056 16455110 16461396 16461398 16461401 16461411 16468079 16468080 16468081 16468082 16468196 16468197 16468198 16468199 16468200 16469897 16474392 16479191 16488020 16503686 16527419 16550170 16574848 16598590 16598591 16601178 16604645 16612167 16612169 16620622 16620623 16620624 16620654 16626427 16626428 16641391 16650692 Bio-ID Spare Part Catalog Number: 353200-01 UDI-DI code: 10885403450136 No Serial/Lot Numbers provided since BD CareFusion is not the manufacturer of the spare parts.
Recalling Firm/ Manufacturer	CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
For Additional Information Contact	Connor L Bates 619-614-3771
Manufacturer Reason for Recall	Due to fingerprint scanner failing resulting in the scanner heating up.
FDA Determined Cause ²	Nonconforming Material/Component
Action	On 1/23/2025, the firm sent a "Urgent Medical Device Correction" Letter via FedEx and email to customers informing them that the firm became aware via customer complaints that an internal component within the Bio-ID (fingerprint scanner) is failing and resulting in the Bio-ID scanner heating up and could potentially cause superficial burns if finger is left on the scanner for up to or more than 5 seconds. Customers are instructed: 1. BD Pyxis" SupplyStation" and MedFlex 2.0 can continue to be used as intended. If you suspect that the Bio-ID Scanner is hot, please discontinue the use of the Bio-ID Scanner, submit a complaint to BD, and use your username and password to login instead. 2. Please return the customer response form to acknowledge receipt of this notice. For questions/assistance: -Technical Support - Phone: 1-866-930-9251 Phone hours: 24 hours, 7 days a week for Technical Questions. -Regional Complaint Center - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted. Mon-Fri 8:00am-5:00pm CT or Email: productcomplaints@bd.com for Product Complaints -Field action related questions - Email (pending) - Email for receipt of customer response forms and recall related questions.
Quantity in Commerce	229 MedFlex and 3,154 spare Bio-ID spare parts
Distribution	Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, and WY. The countries of Australia, Bahrain, Belgium, Brazil, Canada, Hong Kong, Kuwait, Lebanon, New Zealand, Qatar, Saudi Arabia, Spain, and Thailand.
Total Product Life Cycle	TPLC Device Report

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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