FDAFDA · Food and drugs·Recall number Z-2451-2024
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
Published August 7, 2024 · Recall initiated: June 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Domestic: Nationwide Distribution. International: Pending
- Lot
- UPN: M0068318261 (Pack of 5), M0068318260 (Individual Pack); UDI/DI: 08714729842224 (Pack of 5), 08714729842804 (Individual Pack); Lot Numbers: 30110296, 30110298, 30254839, 30269668, 30277679, 30340398, 30348745, 30361515, 30369786, 30477997, 30485719, 30502470, 30509859, 30566414, 30571306, 30579075, 30594738, 30597768, 30601523, 30601525, 30608273, 30621482, 30622202, 30628533, 30642670, 30671135, 30825890, 30834186, 30849605, 30853891, 30862718, 30870581, 30877151, 30880729, 31248068, 31305827, 31316815, 31324676, 31400076, 31442842, 31459986, 31475463, 31479225, 31488049, 31494812, 31502318, 31509747, 31514250, 31583783, 31592632, 31600746, 31609045, 31621292, 31764817, 31779852, 31791062, 31809880, 31821132, 31866608, 31876830, 31876835, 31876837, 32040502, 32057254, 32146583, 32163271, 32230325, 32238124, 32351364, 32361264, 32370219, 32385442, 32400087, 32409539, 32418519, 32420869, 32447685, 32456405, 32465857, 32478780, 32499939, 32515625, 32518619, 32526697, 32829992, 32915635, 32979863, 32998255, 33008248, 33017302, 33065907, 33069479, 33216295, 33236632, 33259078, 33283648, 33311001, 33319579, 33375040, 33383769, 33394221, 33404930, 33422407, 33424886, 33454127, 33479450, 33530347, 33556283, 33564420, 33618759, 33670919, 33676308, 33815834
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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