Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 451
FDA device recall Z-1291-2015 · posted 2015-03-18 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- Reason for recall
- Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
- Action taken
- The firm sent out letters to customers on 02/11/15. The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number. The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification. The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MMP
- Quantity affected
- 172
- Distribution
- Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
- Date initiated
- 2015-02-11
- Date posted
- 2015-03-18
- Date terminated
- 2015-05-21
- Location
- Orange, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (K962288) | Pinnacle Products, Inc. | 1997-01-30 |