Agency classClass IIOur severity:High FDA (Devices)·Z-1698-2023·Announced 2023-06-14

Magic3 Go Female Intermittent Urinary Catheters Recalled for Packaging Defect

C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The defect—label separation potentially compromising sterility—represents a risk of harm to patients using the catheters, fitting the criterion for High severity when injury has not yet been reported.

Plain-English summary

C.R. Bard Inc is recalling Magic3 Go Intermittent Urinary Catheters, Female in six catalog numbers with specific lot numbers. The recall affects approximately 9.9 million devices distributed worldwide.

The catheters are being recalled due to a manufacturing defect where the clear resealing label may separate from the foil product pouch. This separation creates a possible opening in the packaging that could compromise the product's sterility.

No illnesses or injuries have been reported in connection with this recall. Sterile intermittent urinary catheters are medical devices for patients who require catheterization.

Patients and healthcare facilities should verify their stock against the catalog numbers and lot numbers identified in the recall notice.

The recalled product

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
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urinary Catheter
Hazard: packaging-defect
sterility-compromise
Affected units: 9,894,922

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · C.R. Bard Inc

See all →

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C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
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C.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
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Same hazard · packaging defect