PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 recall
PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…
Why was PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 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?
0200136B 0343780C 0441296C 0443152C 0540019C 0543638D 6112014 7312014 0845029D 0847459D 0847460D 0848127D 0940087D 0941072D 0943442D 0943690D 0944823D 1040626D 1040928D 1041984D 1043027D 1044518D 1045056D 1046104D 1046956D 1140857D 1141971D 1142616D 1143647D 1144959D 1145342D 1145878 1145878D 1146673D 1241510D 1242259D 1243096D 1243551 1243551D 1244182 1244645 1245796 1245797 1245797D 1245978 1245978H 1246407 1340934 1340934H 1341256 1341256H 1344090 1440292 1441860 1442306 9801674S
- Product
- PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 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)