Urological Irrigation Kit Recalled for Illegible Barcode Labels
Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a Class III FDA recall involving a documentation issue (illegible barcode) with no reported illnesses, injuries, or adverse events. The hazard is operational, affecting product tracking and inventory control rather than patient safety.
Plain-English summary
MED-RX Urological Cysto/Bladder Irrigation Sets (model REF 10-4001) are being recalled due to illegible barcodes on product labels. The barcode defect prevents successful scanning of the packages, affecting approximately 9,100 units distributed in the United States.
The recalled lots are: Lot Number 159603 (expiration 2026-12-01) and Lot Number 166945 (expiration 2027-06-01). The product is manufactured by Canadian Hospital Specialties.
Healthcare facilities and users in possession of these lots should verify barcode legibility before use. Facilities should contact Canadian Hospital Specialties with questions about the recall or to arrange for replacement products.
The recalled product
- Product
- MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
- Manufacturer
- Canadian Hospital Specialties
- Hazard
- Affected units
- 9,100
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 (4)
- UDI/DI: 00628725001050
- Lot Numbers: 159603
- exp 2026-12-01 and 166945
- exp 2027-06-01
Distribution
Distribution scope not specified by the agency.
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