Recall archive / FDA device enforcement
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous d... — FDA record Z-2222-2024
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 May 15, 2024. 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
- Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230
- Reason
- Product labels state the incorrect expiration dates that extends beyond their true expiration date
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 15 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2222-2024
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)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MA Foreign: Spain, and Netherlands
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
- Jul 3, 2024
- Recall initiation date
- May 15, 2024
- Center classification date
- Jun 27, 2024
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.