FDAClass IIDecember 24, 2014

PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic recall

PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs…

Why was PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic 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?

41350 44269 442637 647415 743732 845623 846466 846767 847691 940788 941241 941606 942276 942920 943500 943533 945623 1040414 1041622 1042249 1042620 1042673 1042674 1042675 1046593 1047021 1140650 1142620 1143129 1144315 1144939 1145976 1146830 1240976 1242463 1244169 1246128 1246649 1341525 1341993 1342760 1343129 1346546 1346648 1440442 1442804

Product
PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs…
Recalling firm
Stryker Endoscopy
Quantity
180,573 units
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)
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