FDAFDA · Food and drugs·Recall number Z-0441-2015
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Published December 3, 2014 · Recall initiated: November 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
- Lot
- Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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