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U.S. Department of Health and Human Services

Class 2 Device Recall BARD Magic3 GO

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  Class 2 Device Recall BARD Magic3 GO see related information
Date Initiated by Firm April 20, 2023
Date Posted June 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-1698-2023
Recall Event ID 92082
510(K)Number K150345  
Product Classification Catheter, straight - Product Code EZD
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
Code Information 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
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact
770-784-6100
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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
Quantity in Commerce 9894922 devices
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EZD and Original Applicant = C.R. BARD, INC.
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