FDAClass IIDecember 24, 2014

PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 recall

PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…

Why was PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 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?

37337 39276 40855 45334 46942 47033 48780 50850 62344 76661 77519 78578 79857 81804

Product
PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…
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)
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