Device product
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
Z-1699-2023
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 92082
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7427880 devices
- Official record key
device-enforcement:Z-1699-2023
Official wording
Reason: 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.
Code information: a) REF 50810G, UDI/DI 0 801741137006; Lot Numbers: JUGV1658; b) REF 50812G, UDI/DI 0 801741137013; Lot Numbers: JUGU0844, JUGV1290, JUGW9017; c) REF 50814G, UDI/DI 0 801741137020; Lot Numbers: JUGS1485, JUGT0238, JUGT0980, JUGT1000, JUGT1710, JUGT2735, JUGT3299, JUGT3353, JUGU0874, JUGU1917, JUGU1956, JUGV0295, JUGV0665, JUGV1277, JUGV1682, JUGW0073, JUGW0812, JUGW1444, JUGW1859; d) REF 50816G, UDI/DI 0 801741137037; Lot Numbers: JUGT0239, JUGT0289, JUGT1010, JUGT1690, JUGT2703, JUGT3399, JUGU0783, JUGU1969, JUGU9049, JUGV0317, JUGV0666, JUGV0690, JUGV9055, JUGX9006; e) REF 50818G, UDI/DI 0 801741137044; Lot Numbers: JUGT9170, JUGT9173, JUGU1788; f) REF 53810G, UDI/DI 0 801741136948; Lot Numbers: JUGQ0944, JUGQ3276, JUGT2737, JUGT9167, JUGU9029, JUGU9035, JUGU9038, JUGU9044, JUGU9051, JUGV9053, JUGX1267, JUGX1988; g) REF 53812G, UDI/DI 0 801741136955; Lot Numbers: JUGQ0939, JUGQ3264, JUGR1444, JUGR2031, JUGS0633, JUGS2403, JUGS3215, JUGT1012, JUGT1711, JUGT2705, JUGT3400, JUGU0845, JUGU1919, JUGV0667, JUGV1292, JUGV9148, JUGW0794; h) REF 53814G, UDI/DI 0 801741136962; Lot Numbers: JUGQ3265, JUGR0224, JUGR1388, JUGR2051, JUGS0048, JUGS0610, JUGS1399, JUGS2381, JUGS3219, JUGT0299, JUGT1019, JUGT1691, JUGT2738, JUGT3301, JUGT3356, JUGU0875, JUGU1905, JUGU1971, JUGV0296, JUGV0692, JUGV1279, JUGV1681, JUGW0814; i) REF 53816G, UDI/DI 0 801741136979; Lot Numbers: JUGQ3277, JUGR1380, JUGR1882, JUGR1883, JUGR2032, JUGR9053, JUGR9056, JUGS2404, JUGT1013, JUGT1712, JUGT2706, JUGT3401, JUGU0846, JUGU1957, JUGV1293, JUGV1659, JUGV9056, JUGW0044, JUGW1861; j) REF 53818G, UDI/DI 0 801741136986; Lot Numbers: JUGR9043, JUGR9057, JUGU9050, JUGV9024, JUGV9048; k) REF 53820G, UDI/DI 0 801741136993 Lot Numbers: JUGR9001, JUGR9002, JUGV1660, JUGX1268, JUGX1989
Distribution pattern: Worldwide
Derived failure modes
-
Manufacturing or process control
manufacturing defect