Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open 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 has recalled approximately 21,250 Capio SLIM Suture Capturing Devices (Model #M0068318250) used to assist in suture placement during open surgery. The devices were distributed worldwide across numerous countries including the United States, Canada, Mexico, countries throughout Central and South America, Europe, Asia, the Middle East, and Australia. The recall was initiated because the sutures in these devices have the potential to break and/or detach during use.
The affected devices are identified by UDI 08714729842224 and can be verified by checking the batch number against the extensive list provided in the recall notice. The source document does not specify a remedy or corrective action for consumers who have these devices.
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: 21,250 Lot/code info: UDI:08714729842224. Batch numbers: 17781206 19335463 20312941 17782808 19435078 20423794 17790316 19568158 20453711 17792469 19573475 20453712 17986321 19701151 20475301 17991696 19711511 20484084 18106407 19833973 20484085 18110253 19858683 20532136 18213570 19858950 20628943 18304052 19882066 20633409 18384108 19882067 20637817 18407974 19887279 20693087 18420687 19942844 20697608 18492494 19959781 20838671 18494737 19963492 20838674 18620481 19993297 20838675 18740238 20000796 20838676 18792184 20001160 20902944 18855259 20001161 20968694 18922488 20006757 21065530 18925301 20009446 21135395 19027722 20017944 21166978 19138109 20202691 21168424 19173080 20203473 21168425 19243603 20305797 21258657 19243604 20305799 21362103 19335462 20305920 21386335
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.