Boston Scientific Corporation: Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Is my product affected?

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

• UPC 08714729516545

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling 1,258 units of the Capio CL suture placement device (Model #M0068311350), which is used in transvaginal procedures. The recall is due to a potential for the Capio sutures to break and/or detach during use. The affected product was distributed worldwide across numerous countries including the United States, Canada, the United Kingdom, Japan, Australia, and many others.

The recalled units are identified by UDI 08714729516545 and are associated with specific batch numbers ranging from 18011270 to 20850569. The recall record does not specify a remedy or instructions for what affected consumers should do regarding the recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for Capio sutures to break and /or detach.

Details from the source

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: 1,258 Lot/code info: UDI:08714729516545. Batch numbers: 18011270 18245411 19491588 18011271 18654941 19668541 18229999 18881759 19987267 20602764 19173286 20382965 20602764 20850569 21234964

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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.2018-02-12
• Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.2018-02-12
• Capio Open Access Box 4 (Capio OPC); Model #M0068311251. 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.2018-02-12
• 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.2018-02-12
• Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.2018-02-12

All FDA (Device enforcement) recalls