Z-2452-2024 Class II Ongoing
FDA device recall Z-2452-2024 was initiated by Boston Scientific Corporation on Jun 27, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 70,890 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2024
- Initiation Date
- Jun 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,890 units total
Product Description
Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
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 Pattern
Domestic: Nationwide Distribution. International: Pending
Code Information
UPN: M0068318250; UDI/DI: 08714729838005; Lot Numbers: 29729168, 29729169, 29972338, 30110291, 30110294, 30254836, 30254837, 30331858, 30338212, 30362314, 30367934, 30434163, 30437947, 30551935, 30598976, 30842709, 30860944, 30993213, 30997334, 31005909, 31257604, 31292169, 31352417, 31367044, 31535491, 31544821, 31554784, 31574100, 31574101, 31624545, 31638194, 31648501, 31727288, 31755722, 31856165, 31856166, 31876917, 31876918, 31876919, 31942747, 31942748, 31984730, 32016719, 32085084, 32259390, 32267863, 32664886, 32699058, 32725350, 32812025, 32842293, 32860360, 32880070, 32988931, 33130079, 33140587, 33530549, 33550168, 33612444, 33753765, 33817740.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2452-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026