Recall Z-1617-2018— Boston Scientific Corporation

Name: FDA recall Z-1617-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-12

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-02-12, terminated 2020-04-10. It names one FDA 510(k) clearance: K172060. Product: 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.. Reason: Potential for Capio sutures to break and /or detach..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Terminated: 2020-04-10
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K172060 — Capio SLIM Suture Capturing DeviceBoston Scientific Corporation·cleared 2017-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Potential for Capio sutures to break and /or detach.

Data sourced from openFDA. This site is unofficial and independent of the FDA.