| Class 2 Device Recall CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT | |
Date Initiated by Firm | June 23, 2022 |
Date Posted | August 17, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1526-2022 |
Recall Event ID |
90650 |
510(K)Number | K200913 |
Product Classification |
Kit, test, pregnancy, hcg, over the counter - Product Code LCX
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Product | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260 |
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
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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 |
Action | On 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 Commerce | 128 units |
Distribution | Product distributed to Family Dollar retail stores in US nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LCX
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