Controlled substance safe towers recalled over fluid ingress causing smoke or fire
CareFusion is recalling 443 BD Pyxis CII Safe ES Tower Main 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 storage unit is a hazard, and no injuries are reported.
Plain-English summary
The BD Pyxis CII Safe ES Tower Main, REF 1116-00, is being recalled across all serial numbers.
Potential fluid ingress of the anesthesia station or med station may result in smoke, system downtime and/or fire.
The recall covers 443 units carrying UDI 10885403512605, 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
- All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 443
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)
- Ref #/UDI: 1116-00 10885403512605
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.
See all 5 products in this recall →Related recalls
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