CSI, Orbital Atherectomy System recall
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a…
Why was CSI, Orbital Atherectomy System recalled?
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, 145946, and 127026
- Product
- CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a…
- Recalling firm
- Cardiovascular Systems Inc
- Quantity
- 18
- Distribution
- US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX
- Recall date
- September 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)