Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Reported: May 16, 2018 Initiated: February 12, 2018 #Z-1618-2018
Product Description
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Reason for Recall
Potential for Capio sutures to break and /or detach.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 1,258
- 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, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.. Recalled by Boston Scientific Corporation. Units affected: 1,258.
Why was this product recalled? ▼
Potential for Capio sutures to break and /or detach.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1618-2018.
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