CareFusion 303, Inc.: BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

Hazard

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.

Details from the source

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. Distribution: 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. Quantity: 1521 Lot/code info: User Guides: i. BD Pyxis MedBank Cabinet User Guide v2.4 ii. BD Pyxis MedBank MedPass User Guide v1.0 iii. BD Pyxis MedBank CR Station User Guide v3.10 iv. BD Pyxis MedBank myQLink Cloud Software User Guide v1.5 v. BD Pyxis Supply Cabinet Safety Guide (for SupplyBank models) Quick Reference Guides: i. BD Pyxis MedBank CR Station QRG (part number 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 Numbers: 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, 1447249

UPC codes

10885403512704, 10885403517167

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.