Smiths Medical ASD, Inc. is recalling approximately 83,833 CADD Solis HSPCA Pumps in the United States and 71,843 items internationally. The recall was initiated because the pumps' wireless connection modules may experience intermittent connection alarms, which can cause an active infusion to stop. This affects pumps running software versions 4.0, 4.1, 4.2, 4.2.1, and 4.3. The manufacturer has provided instructions to healthcare facilities to address the connection issues through a software update or device correction.
If an infusion is interrupted or delayed due to a wireless connection alarm, it can lead to a gap in patient therapy. Depending on the medication being delivered, this delay can cause serious patient injury or death.
Quantity affected: US: 83,833 items; OUS: 71,843 items.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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