Z-0285-2024Class II
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Young Dental Manufacturing Co 1, LLC. / initiated 2023-10-06 / Open, Classified / root cause: packaging
Young Dental Manufacturing I, LLC began a recall of CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles on . FDA classified it as Class II and gives the reason as "one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0285-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Young Dental Manufacturing Co 1, LLC.
- Product
- CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
- Product code
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental
- Reason for recall
- one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- Young Dental Manufacturing CO 1, LLC issued a MEDICAL DEVICE RECALL notice to its consignees on 10/06/2023 by USPS certified mail with return receipt notification. The notice explained the issue and requested that the product be returned or destroyed. Distributors were directed to notify their customers. Replacement product will be provided directly from the recalling firm; refunds will be handled through the distributor and credit issued.
- Quantity in commerce
- 12 units
- Distribution
- US: IN, TN, MO
- Product codes and lots
- UDI/DI 10302731631127, Lot Number 223466
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0285-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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