Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
This recall has been terminated (originally issued July 2, 2014).
- Company
- Microline Surgical, Inc.
- Recall Initiated
- May 12, 2014
- Posted
- July 2, 2014
- Terminated
- August 13, 2015
- Recall Number
- Z-1987-2014
- Quantity
- 6290 units
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Distribution
Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
Lot / Code Info
Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278
Root Cause
Nonconforming Material/Component
Action Taken
Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.