Medication dispensing cabinets recalled after a firmware update caused drawer failures

Plain-English summary

BD Pyxis MedStation ES and related automated dispensing cabinets, including REF 323, REF 324, REF 352, the BD Pyxis Pro 7-Drawer Auxiliary (REF 1149-00) and the BD Pyxis Pro 7-Drawer Auxiliary with Secure Tower (REF 1152-00), are being recalled by CareFusion 303, Inc.

Automated Dispensing Cabinets received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event prompting the software to generate a duplicate address. The firm states this causes an error and the drawer to fail, which may lead to an inability or delay in accessing stored items, delay in the replenishment of the cabinets, or medications specific to a patient being stored outside of them.

The record lists 53,669 units running firmware version 1.48, with REF and UDI-DI pairings listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Colorado, Indiana, Ohio, Texas, Kansas, Florida, Georgia, North Carolina, California, Hawaii and Illinois among other states. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow the firm's instructions.

The recalled product

Product

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main,

Manufacturer

CareFusion 303, Inc.

Category

Medical Device — Dispensing cabinet

Hazard

• firmware-fault
• drawer-failure
• medication-access-delay

Affected units

53,669

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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