Recall Z-1699-2023

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, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G

Codes / lots: a) REF 50810G, UDI/DI 0 801741137006; Lot Numbers: JUGV1658; b) REF 50812G, UDI/DI 0 801741137013; Lot Numbers: JUGU0844, JUGV1290, JUGW9017; c) REF 50814G, UDI/DI 0 801741137020; Lot Numbers: JUGS1485, JUGT0238, JUGT0980, JUGT1000, JUGT1710, JUGT2735, JUGT3299, JUGT3353, JUGU0874, JUGU1917, JUGU1956, JUGV0295, JUGV0665, JUGV1277, JUGV1682, JUGW0073, JUGW0812, JUGW1444, JUGW1859; d) REF 50816G, UDI/DI 0 801741137037; Lot Numbers: JUGT0239, JUGT0289, JUGT1010, JUGT1690, JUGT2703, JUGT3399, JUGU0783, JUGU1969, JUGU9049, JUGV0317, JUGV0666, JUGV0690, JUGV9055, JUGX9006; e) REF 50818G, UDI/DI 0 801741137044; Lot Numbers: JUGT9170, JUGT9173, JUGU1788; f) REF 53810G, UDI/DI 0 801741136948; Lot Numbers: JUGQ0944, JUGQ3276, JUGT2737, JUGT9167, JUGU9029, JUGU9035, JUGU9038, JUGU9044, JUGU9051, JUGV9053, JUGX1267, JUGX1988; g) REF 53812G, UDI/DI 0 801741136955; Lot Numbers: JUGQ0939, JUGQ3264, JUGR1444, JUGR2031, JUGS0633, JUGS2403, JUGS3215, JUGT1012, JUGT1711, JUGT2705, JUGT3400, JUGU0845, JUGU1919, JUGV0667, JUGV1292, JUGV9148, JUGW0794; h) REF 53814G, UDI/DI 0 801741136962; Lot Numbers: JUGQ3265, JUGR0224, JUGR1388, JUGR2051, JUGS0048, JUGS0610, JUGS1399, JUGS2381, JUGS3219, JUGT0299…

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-1699-2023
Initiated
April 20, 2023
Posted by FDA
June 8, 2023
Product code
EZD – Catheter, Straight
Quantity
7427880 devices
Distribution
Worldwide
Recalling firm
C.R. Bard Inc, Covington, GA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1698-2023 Class IIMagic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, 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