BD Pyxis Mini Main cabinets may overheat at fingerprint scanner
BD Pyxis Mini Main medication cabinets are being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn. 709 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall where a component may reach a burn-capable temperature, a risk of harm with no injuries reported in the source.
Plain-English summary
The BD Pyxis Mini Main medication cabinet, REF 349, is being recalled. The action covers 709 units, spanning all serial numbers under UDI 10885403512582.
The stated reason is that the fingerprint scanner may overheat to a temperature able to cause a first degree burn. The FDA classified the action as Class II.
Distribution was nationwide in the United States and to markets including the United Arab Emirates, Australia, Belgium, Bahrain, Brazil, Canada, Chile, Spain, the United Kingdom, Italy, Kuwait, Morocco, Mexico, New Zealand and Portugal. The cabinets are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected cabinets using the REF and UDI above and follow the instructions issued by BD.
The recalled product
- Product
- BD Pyxis Mini Main REF: 349 Medication cabinet
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 709
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/UDI:10885403512582
Distribution
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
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