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.
Recall
- Recall Number
- Z-1635-2014
- Event Number
- 68012
- Firm
- Microline Surgical
- FEI Number
- 1000137656
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 14, 2014
- Posted
- May 20, 2014
- Terminated
- September 2, 2015
- Address
- 50 Dunham Rd, Beverly, MA, 01915-1882
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.
Grasper jaw may break when force is applied to the jaw
Microline Surgical sent an Recall Notice dated April 14, 2014, via overnight mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please contact Microline Customer Service ( 978) 922-9810 for a RGA number to return all unused product. This recall should be carried out to the hospital level. Please complete and return the enclosed response form as soon as possible.
Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
540 units