Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire
CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: fluid ingress that may cause smoke or fire in a clinical dispensing unit is a hazard, and no injuries are reported.
Plain-English summary
Various models of BD Pyxis Pro 7-Drawer Auxiliary, reference numbers 1149-00 and 1152-00, are being recalled.
Potential fluid ingress of the anesthesia station or med station may result in smoke, system downtime and/or fire.
The recall covers 32 units across all serial numbers, carrying UDIs 10885403517822 and 10885403517839, distributed worldwide including nationwide in the United States and to Canada, the United Arab Emirates and Australia. The FDA has classified the action as Class II.
The enforcement record describes the failure mode and reports no injuries. Facilities operating affected units should follow the firm's instructions.
The recalled product
- Product
- Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers/Ref #/UDI: 1149-00 10885403517822 and 1152-00 10885403517839
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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