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

Recall Z-2949-2020 — Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

U.S. FDA — Device Enforcement · United States · 2020-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2949-2020
Date of alert
2020-06-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00886874116845
Reported risk: One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
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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