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.
What this means for you
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
- Hazard
- sterility-breach
- packaging-defect
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.
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