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Recall Observatory FDA recall evidence

Device product

Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222

Z-1987-2014

May 12, 2014

Class II

Product summary

Firm
Microline Surgical, Inc.
Event
Event 68495
Status
Terminated
Classification
Class II
Quantity
6290 units
Official record key
device-enforcement:Z-1987-2014

Official wording

Reason: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw