Boston Scientific Corporation: 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 opera

Is my product affected?

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.

• UPC 08714729470212

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

What happened

Boston Scientific Corporation is recalling 2,567 units of its Capio RP sutures (Model #M0068321010) used in general suturing applications during open surgery. The sutures have the potential to break and/or detach during use. The affected products were distributed worldwide across more than 40 countries, including the United States, Canada, Brazil, Japan, and numerous others. The specific affected batch numbers are: 17813516, 18653139, 19987270, 18014753, 18886132, 20278129, 18015797, 19173287, 20604455, 18015964, 19335466, 20844362, 18234939, 19491590, 21178815, 18237323, 19693866, 21227473, and 21386746.

Consumers who may have these products should identify them using the UDI 08714729470212 and the batch numbers listed above. The recall notice does not specify a remedy or recommended course of action for affected consumers.

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: 2,567 Lot/code info: UDI:08714729470212 Batch numbers: 17813516 18653139 19987270 18014753 18886132 20278129 18015797 19173287 20604455 18015964 19335466 20844362 18234939 19491590 21178815 18237323 19693866 21227473 21386746

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

All FDA (Device enforcement) recalls