Penner Patient Care, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
The device does not bear a unique device identifier.
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →