The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Reason for recall: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. Distribution: Worldwide Quantity: 10833 units Lot/code info: GTIN 08714729965770 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30319836,30359588,30368418,30392647,30409465,30421836, 30442123,30522919,30564343,30577971,30593836,30600837, 30600839,30601021,30616553,30620297,30625219,30638465, 30638467,30638469,30638471,30665570,30666996,30681966, 30681968,30681970,30712588,30725194,30780665,30801487, 30801489,30801491,30811488,30845828,30845830,30845832, 30885087,30890263,30890265,30914070,30922072,30929565, 30935495,30935497,30935499,30981820
08714729965770, 08714729965794
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.