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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 4,144 units of its Capio Standard Box 4 sutures (Model #M0068312321) due to a potential for the sutures to break and/or detach during use. The sutures are intended for general suturing applications in open or endoscopic surgery to assist in suture placement. The affected products were distributed worldwide across numerous countries including the United States, Canada, Brazil, Japan, Australia, and many others, with specific lot/batch numbers and a UDI identifier listed for identification purposes.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for Capio sutures to break and /or detach.
Reason for recall: Potential for Capio sutures to break and /or detach. 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, Isla Quantity: 4,144 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.