Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2122-2017 — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

U.S. FDA — Device Enforcement · United States · 2017-04-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2122-2017
Date of alert
2017-04-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardiovascular Systems Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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