PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N recall
PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
Why was PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, 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?
647989 746662 746663 943683 1040537 1041465 1042439 1043520 1046696 1141788 1144224 1145794 1243095 1244521 1245019 1245817 1341521 1343008 1343551 1344031 1344277 1346244 1346420 1440412 1442624
- Product
- PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 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)