—#199622

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

FDA product code: EZD — Catheter, Straight
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K172247
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: C.R. Bard Inc
Address: 8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2023-04-20
Posted by FDA: 2023-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.