Recall Z-1698-2023

C.R. Bard Inc · initiated April 20, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / 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…

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: 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

Details

Recall number
Z-1698-2023
Initiated
April 20, 2023
Posted by FDA
June 8, 2023
Product code
EZD – Catheter, Straight
Quantity
9894922 devices
Distribution
Worldwide
Recalling firm
C.R. Bard Inc, Covington, GA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1699-2023 Class IIMagic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… 04/20/2023Open, Classified
Z-1700-2023 Class IIMagic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810GSome catheters had a manufacturing defect where the clear resealing label separating from the product foil… 04/20/2023Open, Classified
Z-1701-2023 Class IIHydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… 04/20/2023Open, Classified