Recall archive / FDA device enforcement
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 — FDA record Z-1605-2023
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 Mar 3, 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
- HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
- Reason
- The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
- Classification
- Class II
- Recalling firm
- Access Vascular, Inc
- Quantity
- 240 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1605-2023
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-DI: 00862559000487; Lot Number: 11423949 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to States of: FL, TN, TX.
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
- May 24, 2023
- Recall initiation date
- Mar 3, 2023
- Center classification date
- May 18, 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.