Penner bathing spa 860010-1L recalled for lacking unique device identifier
Penner Patient Care is recalling Pacific Bathing Spa model 860010-1L 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, model number 860010-1L. About 26 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 0085007365409, across 26 listed serial numbers.
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 860010-1L
- 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: 0085007365409
Distribution
Distributed nationwide across the United States.
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