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Recall Observatory FDA recall evidence

Device product

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.

Z-1621-2018

February 12, 2018

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 79608
Status
Terminated
Classification
Class II
Quantity
2,567
Official record key
device-enforcement:Z-1621-2018

Official wording

Reason: Potential for Capio sutures to break and /or detach.

Code information: UDI:08714729470212 Batch numbers: 17813516 18653139 19987270 18014753 18886132 20278129 18015797 19173287 20604455 18015964 19335466 20844362 18234939 19491590 21178815 18237323 19693866 21227473 21386746

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for Capio sutures to break and /or detach.