FDAJune 10, 2020device
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
intuitive surgicalintuitive
UPCs
00886874119129
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-232026-03-25
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