C.R. Bard Inc: Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818

Hazard

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

Details from the source

Reason for recall: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. Distribution: Worldwide Quantity: 9894922 devices Lot/code info: a) REF 51808, UDI/DI 00801741097836; Lot Numbers: JUGP9399, JUGQ0458, JUGR9004, JUGR9010, JUGR9013, JUGR9019, JUGR9020, JUGR9021, JUGT1006, JUGT9147, JUGT9148, JUGU9025 b) REF 51810, UDI/DI 0 801741097850; Lot Numbers: JUFV1857, JUFX9006, JUFX9009, JUFX9028, JUGT9156, JUGT9187, JUGV9129, JUGV9132, JUGV9134, JUGX9047; c) REF 51812, UDI/DI 0 801741097874; Lot Numbers: JUFX1968, JUFX2028, JUFX2811, JUFX2824, JUFX9011, JUFY1816, JUFY9030, JUFZ0452, JUGN9233, JUGN9259, JUGN9305, JUGP0305, JUGP2374, JUGP2977, JUGP9252, JUGP9255, JUGP9264, JUGP9320, JUGQ0934, JUGQ3016, JUGR0220, JUGR1383, JUGR2025, JUGR2044, JUGS0010, JUGS0627, JUGS2397, JUGT0319, JUGT0981, JUGT1706, JUGT1735, JUGT2731, JUGT3323, JUGU0870, JUGU1952, JUGU1965, JUGV0313, JUGV0653, JUGV9165, JUGW0065, JUGW1831; d) REF 51814, UDI/DI 0 801741097898; Lot Numbers: JUFW0450, JUFW1146, JUFW1179, JUFW1753, JUFW2655, JUFW2684, JUFX2030, JUFX2050, JUFX2051, JUFX2812, JUFX2825, JUFX2826, JUFX9008, JUFY1596, JUFZ0451, JUFZ0455, JUFZ0781, JUFZ0782, JUFZ0926, JUFZ0927, JUFZ0984, JUFZ0997, JUFZ0998, JUFZ1016, JUGN9126, JUGN9127, JUGN9128, JUGN9296, JUGN9297, JUGP0298, JUGP2375, JUGP2385, JUGP2965, JUGP2966, JUGP2978, JUGP3542, JUGP9222, JUGP9231, JUGP9232, JUGP9330, JUGQ0913, JUGQ0935, JUGQ2192, JUGQ2193, JUGQ3015, JUGQ3052, JUGQ3261, JUGQ3272, JUGQ3274, JUGR0160, JUGR0221, JUGR1384, JUGR1440, JUGR2001, JUGR2026, JUGR2027, JUGR2046, JUGS0629, JUGS1383, JUGT0284, JUGT0998, JUGT1707, JUGT2699, JUGT2701, JUGT2732, JUGT2733, JUGT3296, J

UPC codes

00801741097836, 801741097850, 801741097874, 801741097898, 801741098086, 801741097935

Source

Official record: FDA (Device enforcement) ↗

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