FDAClass IIMay 16, 2018

Capio CL recall

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

Why was Capio CL recalled?

Potential for Capio sutures to break and /or detach.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI:08714729516545. Batch numbers: 18011270 18245411 19491588 18011271 18654941 19668541 18229999 18881759 19987267 20602764 19173286 20382965 20602764 20850569 21234964

Product
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Recalling firm
Boston Scientific Corporation
Quantity
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.
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls