Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 501
FDA device recall Z-0811-2013 · posted 2013-02-13 · Terminated
Recall details
- Recalling firm
- Ultradent Products, Inc.
- Reason for recall
- Incorrect packaging of regular set and fast set cartridges.
- Action taken
- Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- ELW
- Quantity affected
- 32 cartridges
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-02-04
- Date posted
- 2013-02-13
- Date terminated
- 2013-05-30
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) (K972027) | Zhermack S.P.A. | 1997-07-16 |