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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling approximately 60,538 units of the Capio SLIM Box 5 suture device (Model #M0068318261) due to a potential for the sutures to break and/or detach during general suturing applications in open surgery. The device has been distributed worldwide across more than 40 countries including the United States, Canada, Japan, United Kingdom, and many others in Central America, South America, Europe, Asia, and the Middle East.
The affected products are identified by UDI 08714729842224 and multiple batch numbers listed in the recall record. The source document does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for Capio sutures to break and /or detach.
Reason for recall: Potential for Capio sutures to break and /or detach. 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, Isla Quantity: 60,538 Lot/code info: UDI:08714729842224. Batch numbers: 19083076 19490462 20703048 19138102 19575737 20703101 19138104 19579790 20706387 20552143 19583816 20779052 20552145 19588973 20786955 20552147 19604718 20838609 20552300 19715051 20838611 19138106 19720437 20838613 19138108 19730190 20838615 19334997 19760389 20838617 20552153 19818985 20838619 17685429 19825371 20838661 17689642 19868166 20838663 17774102 19868170 20838665 17777555 19873851 20838667 17792395 19873853 20838670 17899922 19945906 20902946 17906429 19950376 20908772 17907124 19965002 20908774 17907855 19998515 20908776 17915689 20000798 20908778 17919851 20001166 20923178 17920787 20005049 20933960 17985873 20061149 20933962 17990901 20061151 20968696 17995421 20061153 20971515 17997519 20061155 20978294 18001945 20078729 21058901 18005330 20079183 21135392 18024683 20179283 21149060 18036357 20179505 21153916 18104991 20183190 21153918 18111726 20183193 21238940 18115409 20189154 21240810 18120488 20196783 21244374 18212832 20260976 21244755 18217456 20275824 21246277 18221332 20300581 21246370 18222053 20300685 21277765 18295603 20300689 21278301 18299439 20300692 21347579 18388438 20305782 21347701 18394085 20331414 21358289 18396171 20331416 21360859 18399797 20331418 21366235 18410457 20355333 21386338 18414187 20359462 21386740 18498497 20359470 21402640 18500136 20360846 21408533 18513753 20367015 21408536 18517656 20416925 21412229 18518037 20417300 20633990 18626569 20417302 20633992 18642959 20417304 20637803 1864507
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.