FDAClass IIDecember 24, 2014

PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. recall

PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue…

Why was PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. 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?

842133 940165 941352 942845 944667 944703 944720 944832 1040108 1042637 1042643 1042645 1046592 1140812 1141975 1142916 1143079 1144213 1144312 1144396 1145815 1146345 1146677 1146688 1246120 1246127 1343126 1344291 1345039 1345098

Product
PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. 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)
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