Agency classClass IIOur severity:High FDA (Devices)·Z-1700-2023·Announced 2023-06-14

Magic3 Go Pediatric Intermittent Urinary Catheters Recalled for Packaging Defect

C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil 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: FDA Class II recall of a pediatric urinary catheter with potential sterility compromise due to manufacturing defect. No reported illnesses or injuries, so the score is limited to 3 per the rubric criterion that theoretical hazards without reported injury are at most 3.

Plain-English summary

The recall covers Magic3 Go intermittent urinary catheters in pediatric sizes. The issue is a manufacturing defect where the clear resealing label separates from the product foil pouch, creating a possible opening into the packaging that could compromise product sterility.

Approximately 5760 devices have been distributed worldwide under Lot Number JUGW1445 and Catalog Number REF 52810G.

Patients and healthcare providers using these catheters should discontinue use of the affected lots and contact C.R. Bard Inc for guidance on replacement units. No illnesses or injuries have been reported at this time, but the potential for contamination exists if the packaging has been compromised.

The recalled product

Product: Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urinary Catheter
Hazard: sterility-breach
packaging-defect
Affected units: 5,760

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 (3)

a) REF 52810G
UDI/DI 00801741136870
Lot Numbers: JUGW1445

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

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Same hazard · sterility breach