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
This recall is currently active, issued June 8, 2023. It was issued by C.R. Bard, Inc..
- Company
- C.R. Bard, Inc.
- Recall Initiated
- April 20, 2023
- Posted
- June 8, 2023
- Recall Number
- Z-1698-2023
- Quantity
- 9894922 devices
- Firm Location
- Covington, GA
- Official Source
- View on FDA website ↗
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 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
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