Recall archive / FDA device enforcement
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN05011... — FDA record Z-0227-2023
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 Sep 20, 2022. 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
- Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
- Reason
- Product may not be sterile
- Classification
- Class II
- Recalling firm
- TELEFLEX LLC
- Quantity
- 7200 catheters
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0227-2023
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 | UDI (01)24026704323245(17)250405(10)74E2200810 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
TN, CA, NC, TX, FL, OH, MO, IL, OR
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 23, 2022
- Recall initiation date
- Sep 20, 2022
- Center classification date
- Nov 11, 2022
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.