Recall Z-1619-2018— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-02-12, terminated 2020-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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
Product description
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.
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.