PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N recall
PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
Why was PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 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?
141317 142334 246391 341054 341055 04102012E 540683 540685 0541433D 0541434D 6172014 0640767D 0644142D 0647413D 0647616D 0742463D 0743206D 0744706D 0745084D 0746367D 0747892D 08152012E 08426254D 0845326D 0845889D 0846254D 0847431D 0940080D 0940786D 0942136D 0944434D 0944806D 0945985D 1040597D 1040799D 1041469D 1042944D 1043499D 1143128D 1145076D 1145982D 1147040D 1245448 1245519 1245737 1246194 1246197 1341543 1341543D 1341568 1341568D 1344132 1344132D 1344679 13446790 1344679D 1345511 1442519
- Product
- PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
- 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)