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U.S. Department of Health and Human Services

Class 2 Device Recall KY JELLY

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 Class 2 Device Recall KY JELLYsee related information
Date Initiated by FirmJune 23, 2022
Date PostedAugust 17, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1547-2022
Recall Event ID 90650
510(K)NumberK201186 
Product Classification Lubricant, personal - Product Code NUC
ProductKY JELLY LUBRICANT 2 FL OZ, SKU 901443
Code Information All product sold between May 1, 2022 - June 10, 2022.
Recalling Firm/
Manufacturer
Family Dollar Stores, Llc.
500 Volvo Pkwy
Chesapeake VA 23320-1604
Manufacturer Reason
for Recall
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
FDA Determined
Cause 2
Storage
ActionOn June 23, 2022, the firm notified affected Family Dollar retail stores via an urgent Pull and Hold notice, effective June 24, 2022. Retail stores were informed that due to a shipping issue, the affected products could not be sold. Stores were instructed to remove affected products from the sales floor and quarantine them. https://www.familydollar.com/file/general/Voluntary_Recall_of_Certain_Over_the_Counter_Products_080522.pdf
Quantity in Commerce5
DistributionProduct distributed to Family Dollar retail stores in US nationwide.
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 = NUC
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