PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N recall
PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
Why was PKG, AXIAL HANDLE, W/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?
41811 140622 140726 140727 140729 342723 345252 544042 544043 644785 645845 645850 645852 645854 648085 06CON06065 744231 744232 745522 746745 840675 842159 842161 842197 842207 846841 846842 846844 846845 846847 846848 846849 846850 846851 846853 846855 942926 942943 942944 942945 942946 942947 942950 942951 942953 942954 942960 942964 943554 1044584 1044800 1045871 1046151 1046152 1046159 1046162 1046165 1140204 1140205 1140659 1140660 1140662 1142190 1142191 1143092 1143093 1143436 1143437 1144693 1144694 1144696 1145106 1145400 1145478 1146161 1146982 1240188 1240189 1241117 1241949 1242400 1243129 1243584 1243585 1244442 1244882 1246186 1246187 1340352 1340493 1340494 1341007 1341164 1341880 1342685 1342858 1344252 1344707 1440353 1442562 1443626 544043 645847
- Product
- PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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)