Class II Recall

Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 5081

Summary

The FDA issued a Class II for Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b by C.R. Bard Inc. Reason: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into.

Details

Source

Device Recall

External ID

Z-1699-2023

Action Date

2023-06-14

Status

Ongoing

Product Description

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

Lot/Code Info: 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, JUGT1019, JUGT1691, JUGT2738, JUGT3301, JUGT3356, JUGU0875, JUGU1905, JUGU1971, JUGV0296, JUGV0692, JUGV1279, JUGV1681, JUGW0814; i) REF 53816G, UDI/DI 0 801741136979; Lot Numbers: JUGQ3277, JUGR1380, JUGR1882, JUGR1883, JUGR2032, JUGR9053, JUGR9056, JUGS2404, JUGT1013, JUGT1712, JUGT2706, JUGT3401, JUGU0846, JUGU1957, JUGV1293, JUGV1659, JUGV9056, JUGW0044, JUGW1861; j) REF 53818G, UDI/DI 0 801741136986; Lot Numbers: JUGR9043, JUGR9057, JUGU9050, JUGV9024, JUGV9048; k) REF 53820G, UDI/DI 0 801741136993 Lot Numbers: JUGR9001, JUGR9002, JUGV1660, JUGX1268, JUGX1989

Quantity Affected: 7427880 devices

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-04-20

Company

C.R. Bard Inc

Covington, GA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 139 device recalls issued in the same week, part of 413 device-related FDA actions this month.

C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C.R. Bard Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does C.R. Bard Inc have FDA actions?

C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1699-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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