FDA Enforcement
Class III
Ongoing
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Recall: Z-1501-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1501-2026
- Event ID
- 98396
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Penner Patient Care, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 18, 2026
- Initiation Date
- August 13, 2025
- Classification Date
- March 9, 2026
- Address
- 101 Grant St, N/A, Aurora, NE, 68818-3200, United States
Description
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Reason
The device does not bear a unique device identifier.
Code Info
UDI-DI: 0085007365402; Serial Numbers: 03203147501 01192957001 06203171301 07203175701 11162597701 11193074801 11193074802 09193074801 09193074802 09193074803
Distribution
US Nationwide distribution.
Quantity
10 units