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Cardiovascular Systems Inc recalls CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Recalled May 31, 2017 · FDA recall Z-2122-2017 · Cardiovascular Systems
Hazard
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. · FDA Class II
Units
1,396
Sold at
US: AK, AL, AR, AZ. , CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, AUSTRIA, GERMANY, JAPAN, SWITZERLAND.
Description
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.
Product
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Manufacturer(s)
Cardiovascular Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →