FDAClass IIDecember 24, 2014

PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 recall

PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…

Why was PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

643881 842494 940776 943017 943491 1040539 1042912 1046180 1046181 1145927 1146348 1240946 1343133

Product
PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…
Recalling firm
Stryker Endoscopy
Quantity
180,573 units total
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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