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FDA (Device enforcement)Recalled 2024-06-27class ii

Boston Scientific Corporation: Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of suture

Hazard

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

Details from the source

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 Quantity: 70,890 units total Lot/code info: 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.

UPC codes

08714729838005

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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