FDAClass IIDecember 24, 2014

PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. recall

PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue…

Why was PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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?

845453 847518 940163 941605 941870 942281 944296 1040421 1041059 1041275 1042260 1042936 1043497 1045031 1047069 1141567 1143115 1144309 1144621 1144658 1145966 1147094 1240953 1242126 1243830 1341467 1341531 1343396 1344685 1440391 1440909 642118

Product
PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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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