PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 recall
PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…
Why was PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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?
3252011 745845 845883 846788 9022010 941843 941848 943109 943437 944139 944198 945233 946003 1040123 1041183 1042099 1042469 1042516 1043505 1044519 1045630 1046957 1140647 1142130 1142238 1142926 1143477 1144344 1144640 1145692 1146657 1340921H 1342738 1342742 1345734
- Product
- PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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)