—#199615

Product

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

FDA product code: EZD — Catheter, Straight
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K150345
Affected 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, JUGT3297, JUGT3325, JUGT3349, JUGT3350, JUGT3397, JUGU0841, JUGU0842, JUGU0871, JUGU0872, JUGU1901, JUGU1915, JUGU1953, JUGU1954, JUGU1966, JUGU1967, JUGV0292, JUGV0293, JUGV0294, JUGV0314, JUGV0315, JUGV0654, JUGV0664, JUGV0677, JUGV0678, JUGV0689, JUGV1288, JUGV1289, JUGV1295, JUGW0810; e) REF 51816, UDI/DI 0 801741098086; Lot Numbers: JUFX1970, JUGP9670, JUGQ0936, JUGR0161, JUGS0013, JUGT9151, JUGU9028, JUGX9004; f) REF 51818, UDI/DI 0 801741097935; Lot Numbers: JUFY2609, JUGT9182, JUGV9131, JUGW9016

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 #199615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.