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U.S. Department of Health and Human Services

Class 3 Device Recall Pacific Bathing Spa

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 Class 3 Device Recall Pacific Bathing Spasee related information
Date Initiated by FirmAugust 13, 2025
Date PostedMarch 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1500-2026
Recall Event ID 98396
510(K)NumberK040772 
Product Classification Bath, hydro-massage - Product Code ILJ
ProductPenner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
Code Information UDI-DI: 0085007365401; Serial Numbers: 12193105601 09246762101 09246762102 07203174301 07205587001 12236633201 12236633202 09216175802 09216175801 05226320101 05216099201 05216099202 10216200701 01203114101 10193088201 10193088202 05205560701 05205559901 07216148001 07216148002 02226267201 02226267202 06246721701 06246721702 05236523001 05236523002 05236523003 03216064601 03216064602 09185135701 09185135702 11246790502 11246790501 04236501905 04236501902 04236501901 04236501904 07226354201 01236448201 01236448202 01236448203 01236448204 01236448205 01236448206 01236448207 01236448208 08142214601 08236570201 05226328502 05226328501 05226328504 05226328505 11195429001 11195429101 09246761301 09246761302 08185103701 01226253101 08195355001 09205628901 09205629001 08246753101 08246753104 08246753105 08246753106 08246753102 08246753103 02236477101 10182928001 10185152601 10236608401 10236608402 09195378101 09195378001 09195378301 09195378201 11195442101 11195442201 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Recalling Firm/
Manufacturer		 Penner Patient Care, Inc.
101 Grant St
Aurora NE 68818-3200
For Additional Information ContactKevin Walls
720-254-5756
Manufacturer Reason
for Recall		The device does not bear a unique device identifier.
FDA Determined
Cause 2		Error in labeling
ActionRecall notification letters were sent to customers beginning 8/13/25. Your facility has been identified as one that has purchased a Penner Bathing Spa and must place the label(s) attached to this letter(s) next to the current serial tag on your existing Penner Spa and, if applicable, Penner Reservoir. The existing serial tags are located on the side of the spa or reservoir. The serial tag is located behind the TV if you have a Penner Premier Spa with a TV in the cabinet. The last 11 numbers on the UDI label should match the serial number of your existing Penner Spa or Penner Reservoir. Please make sure you attach the corresponding UDI label to the correct Penner product. If you have any questions, please don t hesitate to call our office at 1-800-732-0717.
Quantity in Commerce643 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ILJ
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