Z-1635-2014 Class II Terminated
FDA device recall Z-1635-2014 was initiated by Microline Surgical on April 14, 2014 and is designated Class II. Reason for recall: Grasper jaw may break when force is applied to the jaw The recall status is terminated (terminated September 2, 2015). Affected quantity: 540 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- April 14, 2014
- Termination Date
- September 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 540 units
Product Description
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.
Reason for Recall
Grasper jaw may break when force is applied to the jaw
Distribution Pattern
Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
Code Information
Lot Numbers: 00116169 and 00115866