Boston Scientific Corporation: CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (

Hazard

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Details from the source

Reason for recall: The potential for devices to experience inflation and/or deflation performance issues or difficulties. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 2288 units Lot/code info: 1. UPN: 72404430 (12CM PS IZ); UDI-DI: 00191506021313; Lot numbers: 1100489479, 1100489482, 1100553932, 1100553938, 1100553939, 1100559594, 1100568472, 1100592190, 1100592195, 1100602356, 1100602384, 1100604224, 1100604257, 1100604936, 1100667673, 1100667677, 1100691423, 1100523050, 1100489473, 1100489476, 1100559588, 1100568474, 1100546165, 1100568477, 1100523054, 1100568478, 1100559592, 1100489475, 1100559590, 1100546163, 1100572777, 1100546162, 1100523055, 1100568476, 1100553937, 1100546160, 1100572771, 1100572772, 1100559595, 1100489478, 1100553936, 1100523051, 1100572769, 1100489477, 1100523049, 1100546159, 1100489474, 1100572773, 1100546164, 1100604225, 1100602381, 1100602351, 1100592189, 1100604227, 1100602383, 1100602379, 1100592191, 1100604262, 1100604260, 1100592196, 1100604259, 1100667670, 1100670795, 1100670801, 1100667671, 1100667679, 1100667678, 2. UPN: 72404431 (15CM PS IZ); UDI-DI: 00191506021320; Lot numbers: 1100488945, 1100488946, 1100488947, 1100488951, 1100488952, 1100488953, 1100488954, 1100488981, 1100488982, 1100488983, 1100488984, 1100509688, 1100509689, 1100509690, 1100509693, 1100509694, 1100509695, 1100509706, 1100509711, 1100509714, 1100509716, 1100509717, 1100509719, 1100509724, 1100533744, 1100533745, 1100533749, 1100533751, 1100535545, 1100535546, 1100535552, 1100541422, 1100541423, 1100547735, 1100547736, 1100547738, 1100574742, 1100574743, 1100574747, 1100584464, 1100584466, 1100584467, 1100584468, 1100584470, 1100584471, 1100584472, 11005866

UPC codes

00191506021313, 00191506021320, 00191506021337, 00191506021344, 00191506021351, 00191506021368, 00191506021375, 00191506021382, 00191506021399, 00191506021405

Source

Official record: FDA (Device enforcement) ↗

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