Capio Open Access Box 4 recall
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist…
Why was Capio Open Access Box 4 recalled?
Potential for Capio sutures to break and /or detach.
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?
UDI:08714729257615. Batch numbers: 17736884 18743137 19980158 17743915 18744758 20088658 17746353 18831921 20146415 17748695 18952185 20151917 17758603 18956329 20225741 17763024 18960345 20225743 17791930 19046994 20341445 17970678 19046996 20341447 18129693 19046998 20560166 18134147 19173285 20639024 18135271 19225756 20706637 18229178 19329479 20711254 18281817 19437996 20713128 18286295 19442739 20822293 18357019 19560316 20833214 18362244 19646043 20834317 18430411 19646222 20838382 18488288 19659042 21069563 18605754 19824767 21081751 18606004 19835267 21258659 18611631 19856248 21362105 19975069 21362107
- Product
- Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 21,051
- Distribution
- Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)