FDAFDA · Food and drugs·Recall number Z-2171-2014
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Published August 20, 2014 · Recall initiated: June 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Distribution to Florida and South Carolina
- Lot
- Model number 410298-05 and 410298-06
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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