Penner Patient Care recalled 45 Penner Pacific Bathing Spa units distributed nationwide in the United States. The devices do not bear a unique device identifier. Patients and healthcare providers should stop using this device immediately and follow the recall instructions provided by the manufacturer.
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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Penner Pacific Bathing Spa is a patient bathing device used to assist with in-home or clinical bathing for patients. The recall targets a labeling defect rather than device performance.
A missing unique device identifier compromises traceability and postmarket recalls, potentially delaying safety actions.
This recall is not part of a broader industry pattern.
Hospitals or homes using the device should halt use and follow recall guidance to avoid untraceable devices.
Label on the device and any accompanying documentation; recall notice URL provided by FDA
4-8 weeks forrefund or replacement processing
Keep recall letter, photos of device labels, serial numbers, dates of purchase, and all correspondence with the company
Model Numbers: 360020-1P UDI-DI: 0085007365403 Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 032569388
No injuries or incidents have been reported.
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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.
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