Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
FDA device recall Z-0725-2023 · posted 2022-12-19 · Open, Classified
Recall details
- Recalling firm
- Young Dental Manufacturing I, LLC
- Reason for recall
- mislabeled product
- Action taken
- 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
- Status
- Open, Classified
- Product code
- JET
- Quantity affected
- 600 packs
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.
- Date initiated
- 2022-12-05
- Date posted
- 2022-12-19
- Location
- Earth City, MO
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