Penner Patient Care recalled 26 Penner Pacific Bathing Spa units distributed nationwide in the United States after finding they do not bear a unique device identifier. The absence of a UDI prevents reliable traceability of the devices. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall 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 used in some healthcare settings to bathe patients who cannot be easily moved. It may be employed in daily hygiene routines.
A missing unique device identifier prevents traceability and regulatory tracking of the device in medical records and adverse-event systems.
This recall is not described as part of a broader industry pattern.
Facilities may need to identify affected units in inventory and coordinate with the manufacturer for recall steps. No injuries have been reported to date.
Refer to the FDA recall page and the Penner Patient Care notice for instructions.
Remedies or replacements, if offered, typically take weeks to process; specifics not provided in the notice.
Keep the recall notice, product labels, serial numbers, and all correspondence with the manufacturer for your records.
Model numbers: 860010-1L. Sold nationwide in the United States. Sold from unknown date. Price unknown.
No injuries or incidents have been reported.
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