Reported Dec 24, 2014 · Terminated
PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for…
Stryker Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Lot codes and dates
14131714233424639134105434105504102012E5406835406850541433D0541434D61720140640767D0644142D0647413D0647616D0742463D0743206D0744706D0745084D0746367D0747892D08152012E08426254D0845326D0845889D0846254D0847431D0940080D0940786D0942136D0944434D0944806D0945985D1040597D1040799D1041469D1042944D1043499D1143128D1145076D1145982D1147040D1245448124551912457371246194124619713415431341543D13415681341568D13441321344132D1344679134467901344679D13455111442519
- Amount recalled
- 180,573 units total
This recall covers 207 products
The agency filed one notice per product. You are reading one of them; the other 206 are below.
194 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
This product could cause temporary or reversible health problems — stop using it.
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