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
- Company
- C.R. Bard, Inc.
- Recall Initiated
- April 20, 2023
- Posted
- June 8, 2023
- Recall Number
- Z-1699-2023
- Quantity
- 7427880 devices
- Firm Location
- Covington, GA
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
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT