Penner Patient Care, Inc.: Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Read the official notice at FDA (device) →
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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 560010-2L, 560010-XL, 560010-1L, 560010-XL
- 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: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201
- Product quantity
- 15 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Aurora
- State
- NE
- Country
- United States
- Event id
- 98396
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