Reported May 31, 2017 · Terminated
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Cardiovascular Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiovascular Systems Inc · 1225 Old Highway 8 NW · Saint Paul, MN · 55112-6416
Is this the product you have?
- CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only
- Part Number7-10014
- Model NumberSIP-3000
- Lot codes and dates
- Lot Number
451 of 451 codes
9225492693106281106282106283106284106285106286106287106288106290106543118121118223121782123165123489123547123808123878124088124289124925124927124989125310125347125362126696126797126925127026127155127221127348127614127742127834128001128027128132128179128326129266129303132418132839132966133231133429133759133880134057134318134534134966135199135372135791135941
- Lot Number
- Amount recalled
- 1,396
Where it was sold
Why it was recalled
Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.
This product could cause temporary or reversible health problems — stop using it.
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