FDAFDA · Food and drugs·Recall number Z-1635-2014
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Published May 28, 2014 · Recall initiated: April 14, 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
Grasper jaw may break when force is applied to the jaw
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microline Surgical
- Distributor
- Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
- Lot
- Lot Numbers: 00116169 and 00115866
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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