Recall archive / FDA device enforcement
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 — FDA record Z-0575-2022
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 Jan 7, 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
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
- Reason
- Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 449,676 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0575-2022
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 | All lot numbers within expiry |
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
- Feb 16, 2022
- Recall initiation date
- Jan 7, 2022
- Center classification date
- Feb 8, 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.