PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N recall
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
Why was PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, 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?
543367 544893 842088 845454 941849 942135 942844 943742 945442 1040419 1041098 1042499 1042929 1043777 1044526 1044527 1045033 1045372 1047071 1141219 1141973 1142134 1142913 1143973 1144935 1145348 1145796 1146957 1147046 1241906 1243270 1244187 1246179 1341468 1341557 1343701 1344283 1344526 1345529 1346236 1346680 1440403 1440910 1442176 1442809 1443395 1443652 646462
- Product
- PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. 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)