Z-1987-2014 Class II Terminated
FDA device recall Z-1987-2014 was initiated by Microline Surgical, Inc. on May 12, 2014 and is designated Class II. Reason for recall: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw The recall status is terminated (terminated August 13, 2015). Affected quantity: 6290 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2014
- Initiation Date
- May 12, 2014
- Termination Date
- August 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6290 units
Product Description
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Reason for Recall
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Distribution Pattern
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.
Code Information
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