Recall archive / FDA device enforcement
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, ... — FDA record Z-1701-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- C.R. Bard Inc
- Quantity
- 308520 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1701-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) REF 71808, Lot Numbers: JUGU9026; b) REF 71810, Lot Numbers: JUGT9154, JUGU9053, JUGV9130, JUGV9133; c) REF 71812, Lot Numbers: JUGT0236, JUGT1689, JUGT2702, JUGU1955, JUGU1968, JUGV9158; d) REF 71814, Lot Numbers: JUGT3326; e) REF 71816, Lot Numbers: JUGU9023; f) REF 71818, Lot Numbers: JUGT0288, JUGU9022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 14, 2023
- Recall initiation date
- Apr 20, 2023
- Center classification date
- Jun 8, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.