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Open, Classified

Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

FDA Recall Z-0725-2023 · Posted 2022-12-19

Recalling FirmYoung Dental Manufacturing I, LLC
Recall StatusOpen, Classified
Product CodeJET
Date Initiated2022-12-05
Product Quantity600 packs

Reason for Recall

mislabeled product

Firm Action

The firm issued an URGENT: MEDICAL DEVICE RECALL notice on 12/05/2022 to its consignees be certified mail. The notice explains the issue and requests either the return or discarding of the affected product. The response form indicates that their customers will be notified. On 12/19/2022, firm expanded recall to include an additional affected lot. Customers were sent an updated URGENT: MEDICAL DEVICE RECALL notice on 12/19/2022, which included the same instructions.

Root Cause

Employee error

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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