NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless
FDA device recall Z-1034-2017 · posted 2017-01-17 · Terminated
Recall details
- Recalling firm
- Ultradent Products, Inc.
- Reason for recall
- Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
- Action taken
- Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated December 14, 2016, to all affected consignees. The letter instructed consignees to discard remaining inventory and return the response form. For any questions, please call at 801-553-4858.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- EID
- Quantity affected
- 143 packs of 100 tips; 104 packs of 20 tips
- Distribution
- Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.
- Date initiated
- 2016-12-14
- Date posted
- 2017-01-17
- Date terminated
- 2017-06-05
- Location
- South Jordan, UT
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