PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N recall
PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and…
Why was PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, 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?
43984 43987 44362 140498 140859 141064 246307 247408 340607 840366 840912 842117 842499 843735 844138 844601 845041 943743 944837 945749 1040109 1040579 1040937 1041623 1042256 1046590 1140173 1143127 1144355 1144488 1145337 1145813 11I0424 1240116 1240768 1240954 1241907 1242936 1244188 1244530 1246172 1340544 1343298 1343702 1344782 1344879 1344996 1345040 1345099 1346106 1346107 1346681 1440911 1443227
- Product
- PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. 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)