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RecallWatchMedical Device Safety
Class IIOngoingZ-1206-2025

CareFusion 303, Inc. recalls BD Pyxis: MedFlex

CareFusion 303, Inc.San Diego, CA, United StatesReported Mar 5, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

BD Pyxis: MedFlex1 code
  • 1119-00
MedBank Tower1 code
  • 1145-00
MedBank MedPass1 code
  • 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

Lot / code information

Part / Item #
155018-03) ii. BD Pyxis MedBank Cabinet QRG (PN 155023-03) iii. BD Pyxis MedBank RxNow CR Station QRG (PN 155026-03) iv. BD Pyxis MedBank RxNow Solution QRG 2.0 (PN 155027-02) v. BD Pyxis MedBank MedP…Show all
155018-03) ii. BD Pyxis MedBank Cabinet QRG (PN 155023-03) iii. BD Pyxis MedBank RxNow CR Station QRG (PN 155026-03) iv. BD Pyxis MedBank RxNow Solution QRG 2.0 (PN 155027-02) v. BD Pyxis MedBank MedPass QRG (PN 155022-03) vi. BD Pyxis MedBank QFill Station QRG (PN 155020-02) vii. BD Pyxis MedBank myQLink Cloud Software QRG 3.0 (PN 155021-02) REF/UDI-DI/
Serial #
1119-00/10885403512704/13517006, 13523350, 13754724, 13767953, 13789575, 13801727 — +1512 moreShow all
1119-00/10885403512704/13517006, 13523350, 13754724, 13767953, 13789575, 13801727, 13826187, 13879544, 13883357, 13884848, 13934472, 13939327, 13948724, 14032802, 14037891, 14158187, 14159916, 14168580, 14172832, 14175162, 14182716, 14202337, 14220872, 14222746, 14228149, 14228150, 14244101, 14254813, 14254816, 14254812, 14254815, 14275112, 14278095, 14317945, 14317946, 14324386, 14332058, 14347747, 14347748, 14349106, 14348708, 14348709, 14352459, 14365786, 14365785, 14374965, 14374963, 14374964, 14377079, 14378428, 14377908, 14407523, 14407524, 14420205, 14420213, 14420211, 14420207, 14420208, 14420206, 14420223, 14420222, 14420212, 14441382, 14442352, 14442359, 14442686, 14442685, 14442585, 14442586, 14445911, 14456782, 14456757, 14458260, 14458256, 14458259, 14472490, 14472338, 14472980, 14472990, 14472975, 14472981, 14472970, 14472977, 14472982, 14472971, 14472987, 14472973, 14472983, 14472972, 14472961, 14472985, 14472974, 14472989, 14472966, 14472988, 14472984, 14472964, 14472962, 14472968, 14472969, 14472967, 14472979, 14475836, 14475827, 14475839, 14475832, 14475831, 14475830, 14475828, 14475829, 14475837, 14475834, 14475835, 14532831, 14533089, 14540092, 14540091, 14540107, 14540097, 14540103, 14545019, 14549918, 14549926, 14549535, 14549924, 14549537, 14549913, 14549910, 14549934, 14549928, 14549543, 14549534, 14549542, 14549546, 14579394, 14602051, 14602043, 14602044, 14602049, 14602048, 14602050, 14618948, 14635117, 14635121, 14635120, 14635118, 14635122, 14649376, 14651893, 14656794, 14672001, 14678266, 14678259, 14678251, 14678262, 14678240, 14678261, 14678246, 14678258, 14678256, 14695735, 14695732, 14695737, 14695731, 14697048, 14697051, 14697049, 14709300, 14711347, 14711353, 14742553, 14742644, 14743937, 14743923, 14743935, 14743929, 14743932, 14743938, 14743925, 14743933, 14743934, 14743931, 14787943, 14787944, 14787922, 14787923, 14787942, 14787939, 14787919, 14787940, 14803084, 14834314, 14861749, 14861747, 14868948, 14883876, 14888627, 14888639, 14894201, 14894199, 14894200, 14894202, 14897578, 14897577, 14925753, 14942508, 14951354, 14951344, 14951377, 14951386, 14951338, 14958134, 14977993, 14990472, 14990476, 15024805, 15070091, 15086034, 15086026, 15125781, 15125782, 15125773, 15125779, 15125784, 15125777, 15125778, 15125776, 15125772, 15169037, 15176582, 15176580, 15201877, 15201878, 15206270, 15206267, 15206269, 15210095, 15210091, 15210094, 15210089, 15210104, 15210088, 15210090, 15210106, 15213239, 15216160, 15223570, 15223560, 15223568, 15223571, 15229115, 15229108, 15229107, 15229119, 15229118, 15236627, 15240793, 15242603, 15242599, 15242596, 15242602, 15242605, 15242606, 15245775, 15245774, 15245776, 15245777, 15253442, 15254778, 15254776, 15254774, 15254772, 15254775, 15268840, 15268836, 15268851, 15268838, 15268856, 15268850, 15268835, 15279442, 15279443, 15279444, 15279455, 15279458, 15279454, 15290675, 15294474, 15299940, 15308354, 15317099, 15317097, 15317100, 15317104, 15317101, 15317102, 15322148, 15322145, 15340242, 15340240, 15340245, 15340241, 15340239, 15340251, 15340243, 15340238, 15356973, 15356977, 15361554, 15361559, 15361555, 15361553, 15369939, 15389013, 15389673, 15391644, 15391311, 15392443, 15392451, 15392447, 15392449, 15393558, 15396726, 15416741, 15460705, 15460996, 15460706, 15460997, 15460707, 15461858, 15463097, 15463095, 15463096, 15464898, 15470033, 15470035, 15470034, 15471183, 15473693, 15473692, 15474596, 15474551, 15492248, 15492211, 15498908, 15500854, 15509359, 15509361, 15509364, 15509365, 15509366, 15513835, 15513825, 15513834, 15513826, 15513833, 15513830, 15513831, 15517161, 15519704, 15519700, 15521199, 15521203, 15521200, 15521201, 15554707, 15557611, 15561697, 15564895, 15564897, 15564894, 15564893, 15564896, 15583141, 15584199, 15613096, 15614585, 15622613, 15622611, 15622635, 15638496, 15638495, 15643124, 15643125, 15643128, 15647364, 15647367, 15652143, 15652147, 15652138, 15652145, 15661682, 15661681, 15679247, 15679269, 15679254, 15679243, 15679263, 15679237, 15679245, 15682324, 15691543, 15736824, 15736832, 15736823, 15748541, 15748544, 15748543, 15779891, 15788872, 15788870, 15788868, 15803799, 15835058, 15835059, 15853794, 15854592, 15854989, 15855085, 15855653, 15855651, 15855650, 15855649, 15855652, 15906182, 15923716, 15924566, 15924567, 15929989, 15931343, 15933057, 15933056, 15937957, 15940593, 15940620, 15942158, 15942157, 15942159, 15956999, 15957002, 16030464, 16039729, 16045065, 16053361, 16063826, 16066740, 16081624, 16084502, 16089562, 16089561, 16089912, 16090406, 16090401, 16090325, 16090399, 16090308, 16090687, 16091227, 16091885, 16112808, 16112853; 1145-00/10885403517167/15383483, 15389562, 15422138, 15422139, 15442792, 15500700, 15500693, 15504839, 15504841, 15518256, 15518261, 15550844, 15550852, 15550857, 15569626, 15598106, 15600761, 15639702, 15654701, 15654698, 15662824, 15662821, 15684799, 15684812, 15715761, 15715760, 15715748, 15715742, 15723806, 15723817 15728652, 15728657, 15747087, 15761382, 15770179, 15770181, 15770187, 15770221, 15770215, 15770217, 15770207, 15770172, 15806707, 15806718, 15867348, 15928765, 15930653, 15932837, 15935612, 15941687, 15957628, 15958445, 15958444, 15962003, 15962008, 15962006, 15962002, 15962016, 15961996, 15961979, 15961986, 15962018, 15967374, 15967375, 15967376, 15978031, 16006031, 16295928, 16295929, 16295930, 16295931, 16296379, 16296380, 16296360, 16297667, 16297668, 16297669, 16297671, 16300643, 16300642, 16300639, 16300641, 16300640, 16301023, 16301024, 16301018, 16301021, 16301020, 16301015, 16301016, 16302339, 16302328, 16302327, 16302337, 16302343, 16302338, 16302331, 16302332, 16302333, 16302342, 16302340, 16302329, 16302330, 16303465, 16303469, 16303463, 16303466, 16303468, 16303467, 16305129, 16305136, 16305134, 16305130, 16305133, 16306411, 16306401, 16306402, 16306413, 16306408, 16306419, 16306403, 16306397, 16306399, 16306404, 16306393, 16306395, 16308990, 16308989, 16308977, 16308973, 16308987, 16308979, 16308993, 16308998, 1630 …

What the firm is doing

On 1/10/2025, correction notices were mailed or emailed to Directors of Nursing or Nurse Managers, Directors of Pharmacy or Pharmacist In Charge, and Facility Administrators informing them to take the following actions: Customers should do the following to prevent delays in access: a. Ensure staff are aware of updates to User Guides, including: automated dispensing devices should not be used as a crash cart or code box. Medication or items may not be immediately accessible for an emergent situation causing a delay in treatment which could lead to serious injury or death. b. Have device keys available on-site in a secure location known to designated staff c. Train staff on how to manually access the device d. Ensure downtime policies and procedures are implemented and staff are appropriately trained e. Enable Over-ride mode permissions For pharmacies providing automated dispensing device products to clinical users that are not physically located at the pharmacy site, please ensure clinical users are aware of the risk of delay in access and provide access to keys. Firm will be strengthening labeling regarding delays in dispensing medication. Report any issues associated with the above devices via phone at 866-930-9251. Post these notices with the device until labeling has been updated. Complete and return the response form via email to BDRC54@bd.com If you require further assistance, please contact the firm: 1) Technical Support: Website: bd.com/self-service, Phone: 1-866-930-9251, Hours: 24 hours, 7 days a week. 2) BD Recall Operations, BDRC54@bd.com, Fax: (312) 949-0081. 3) Customer Letter Support, Email: PyxisQuestions@BD.com

DistributionShow details

US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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