Recall Z-2122-2017— Cardiovascular Systems Inc
Class II · Terminated
Class II FDA medical device recall by Cardiovascular Systems Inc, initiated 2017-04-14, terminated 2017-10-02. FDA's recall record names no specific 510(k) clearance for this event. Product: CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.. Reason: 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..
- Recalling firm
- Cardiovascular Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-14
- Terminated
- 2017-10-02
- Firm location
- Saint Paul, MN, United States
Product description
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.