PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 recall
PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…
Why was PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 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?
141319 842460 843942 845881 941071 942659 944719 944822 946005 1040386 1040575 1041062 1044649 1046416 1144394 1145399 1146201 1241936 1242457 1243550 1244167 1244959 1246142 1246364 1246663 1341519 1345288 543354
- Product
- PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…
- 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)