Boston Scientific Corporation recalls Capio Standard Box 4 (Capio PC); Model #M0068312321. Inte
Recalled Product
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
Hazard / Issue
Potential for Capio sutures to break and /or detach.
Issued by
FDA
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.
Lot/Code Info: UDI:08714729257622 Batch numbers: 17817547 19050231 20639026 17925410 19225758 20717524 18139200 19335465 21081753 18363737 19437994 21258781 18615714 19698427 21386211 18826587 19983956 20341449 18955689 20341449
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