Penner Patient Care recalled 158 Penner Pacific Bathing Spa devices distributed nationwide in the United States. The device does not bear a unique device identifier. Healthcare providers and patients should stop using the device immediately and follow the recall instructions mailed to affected parties.
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 device used for patient bathing in healthcare and home settings. It is designed to facilitate sponge baths for patients and individuals needing assistive bathing. This recall concerns regulatory labeling rather than a direct device injury issue.
The absence of a unique device identifier hinders regulatory tracking and recall management. It does not specify a direct injury hazard in the recall notice.
This recall is not described as part of a broader industry pattern.
The immediate impact is operational for providers and patients who rely on the device. Action is required to avoid regulatory complications and ensure traceability.
Label on the device, user manual, and the FDA recall listing linked in the notice.
Recall communications by letter with next steps. Replacement or remedies, if offered, will follow manufacturer instructions.
Keep the recall notice, photograph labels, model numbers, and all correspondence with the manufacturer for records.
Model numbers: 361910-1A, 361910-XA, 361910-2I, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X. UDI-DI: 0085007365405. Serial numbers listed by the manufacturer include thousands of entries in the recall notice. Distribution: US nationwide. Sold by: Unknown.
No injuries or incidents have been reported.
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