Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLI
Summary
The FDA issued a Class II for Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, In by Boston Scientific Corporation. Reason: Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical interv.
Details
Source
Device Recall
External ID
Z-2451-2024
Action Date
2024-08-07
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 70,890 units total
Reason for Recall
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Distribution
Domestic: Nationwide Distribution. International: Pending
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-27
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2451-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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