Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Reported: September 16, 2020 Initiated: June 10, 2020 #Z-2949-2020
Product Description
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Reason for Recall
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 67 units
- Distribution
- U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.. Recalled by Intuitive Surgical, Inc.. Units affected: 67 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 16, 2020. Severity: Moderate. Recall number: Z-2949-2020.
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