Recall archive / FDA device enforcement
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) — FDA record Z-1016-2022
Reported terminated
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 Feb 21, 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
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- Reason
- Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- Classification
- Class II
- Recalling firm
- Freudenberg Medical, Llc
- Quantity
- 13 units (US)
- Agency-reported status
- Terminated
- Source record identifier
- Z-1016-2022
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 | Lot Numbers: PD01, PD00013140 UDI: 00850004312001 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution: GA, OH Foreign distribution: 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
- May 4, 2022
- Recall initiation date
- Feb 21, 2022
- Center classification date
- Apr 28, 2022
- Termination date
- Apr 18, 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.