PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, P/N recall
PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, P/N 0250080634 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
Why was PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, 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?
38042 41043 41849 41875 42240 42502 44647 46566 47092 47503 47788 48285 49179 49691 52200 52203 53377 54246 56194 60879 63395 73215 74024 74683 75672 76832 77049 83778 84741 86162
- Product
- PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, P/N 0250080634 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)