Penner Patient Care, Inc. recalled 21 Penner Pacific Bathing Spa units distributed nationwide in the United States after discovering the devices do not bear a unique device identifier. The missing UDI hinders traceability for adverse events and recalls. Consumers should stop using the devices and contact Penner Patient Care for instructions.
The device does not bear a unique device identifier.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Penner Patient Care, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Penner Pacific Bathing Spa is a patient bathing device used in healthcare or care settings. It is referenced in a nationwide US recall for missing UDI information.
The absence of a unique device identifier prevents reliable traceability for recalls and adverse events.
This recall is not described as part of a broader industry pattern.
For consumers and facilities, the missing UDI complicates recall actions and post-market surveillance. No injuries have been reported, but the issue affects traceability.
UDI on device label; serial numbers and model numbers on the device and recall communications; FDA recall page.
Refunds or replacements, if offered, typically processed within 4-8 weeks after eligibility confirmation.
Keep the recall notice, photos of the device, model and serial numbers, and any correspondence with the manufacturer.
Model numbers: 350010-1, 350000-2, 350010-X. Distribution: US nationwide. Recall date: 2025-08-13. Price: Unknown.
No injuries or incidents have been reported.
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