Penner bathing spa 361910 series recalled for lacking unique device identifier
Penner Patient Care is recalling Pacific Bathing Spa models in the 361910 series because the device does not bear a unique device identifier.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Rubric level 1 covers documentation issues, and this FDA Class III recall concerns a missing device identifier marking with no defect or hazard described.
Plain-English summary
Penner Patient Care, Inc. is recalling the Penner Pacific Bathing Spa in the 361910 series, covering model numbers 361910-1A, 361910-XA, 361910-2I, 361910-1, 361910-XI, 361910-1I, 361910-2A and 361910-X. About 158 units were distributed nationwide in the United States. The FDA has classified this recall as Class III.
The device does not bear a unique device identifier. The source record does not describe a defect, malfunction or hazard in the device itself.
Affected product carries UDI-DI 0085007365405, across the serial numbers listed in the FDA enforcement record.
Facilities can identify affected units by the model and serial numbers above, and may contact Penner Patient Care, Inc. for further information.
The recalled product
- Product
- Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
- Manufacturer
- Penner Patient Care, Inc.
- Hazard
- missing-udi
- documentation-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 0085007365405
Distribution
Distributed nationwide across the United States.
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