Penner Patient Care recalled 15 Penner Pacific Bathing Spa devices distributed nationwide to healthcare providers in the United States. The devices do not bear a unique device identifier. Stop using the device immediately and follow recall instructions from the manufacturer or your healthcare provider.
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 medical device used to support hydrotherapy or bathing therapies in clinical or home care settings. It is distributed through healthcare channels and intended for patient care.
The lack of a unique device identifier can hinder postmarket tracking and safe recall actions, potentially delaying manufacturer communications and corrective actions.
This recall is not described as part of a broader industry pattern in the notice.
Healthcare providers and patients may need to identify affected devices quickly to avoid using non-identifiable units. The recall may require replacements or proper labeling to ensure traceability.
Official recall details are on the FDA enforcement page linked in the recall notice. Manufacturer instructions will be provided to healthcare providers.
Remedy processing times are not specified. Expect updates through the FDA notice and Penner Patient Care communications.
Keep the recall letter, model numbers, UDI, serial numbers list, and all correspondence with the manufacturer or provider.
Model numbers: 560010-2L, 560010-XL, 560010-1L. Sold nationwide in the United States. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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