PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 recall
PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue…
Why was PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 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?
35102 36602 38745 39649 40407 47505 48905 51715 52696 63484 65937 70271 71359 73066 78490 79567 79888 85252 86811 87727
- Product
- PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue…
- 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)