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U.S. Department of Health and Human Services

Class 2 Device Recall Caphosol Artificial Saliva

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 Class 2 Device Recall Caphosol Artificial Salivasee related information
Date Initiated by FirmJune 11, 2025
Date PostedJune 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2012-2025
Recall Event ID 97007
510(K)NumberK234015 
Product Classification Saliva, artificial - Product Code LFD
ProductCaphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Code Information UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Recalling Firm/
Manufacturer		 RECORDATI RARE DISEASES INC.
440 Us Highway 22 Ste 205
Bridgewater NJ 08807-2477
For Additional Information ContactAilyn Abin
908-236-0888
Manufacturer Reason
for Recall		Out of specification stability test result for the Caphosol B solution from process validation lots
FDA Determined
Cause 2		Device Design
ActionRecordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter. Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory. Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.
Quantity in Commerce3,754 boxes (120,128 doses)
DistributionWorldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.
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 = LFD
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