Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1698-2023Class II

Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812...

C.R. Bard Inc / initiated 2023-04-20 / Open, Classified / root cause: labeling and UDI

C.R. Bard Inc began a recall of 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 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1698-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
C.R. Bard Inc
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
Product code
EZD Catheter, Straight
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.
Root cause tag
labeling and UDI
FDA root cause
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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1698-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1698-2023Class IIOngoingVoluntary: Firm initiated
Z-1699-2023Class IIOngoingVoluntary: Firm initiated
Z-1700-2023Class IIOngoingVoluntary: Firm initiated
Z-1701-2023Class IIOngoingVoluntary: Firm initiated