Penner Patient Care, Inc.: Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Penner Patient Care, Inc.
- Product
- Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
- Reason / hazard
- The device does not bear a unique device identifier.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2025-08-13
- Code info
- UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401
- Product quantity
- 21 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Aurora
- State
- NE
- Country
- United States
- Event id
- 98396
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