Recall Z-1699-2016— Valeant Pharmacueticals International
Class II · Terminated
Class II FDA medical device recall by Valeant Pharmacueticals International, initiated 2016-01-29, terminated 2017-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.. Reason: It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period..
- Recalling firm
- Valeant Pharmacueticals International
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-29
- Terminated
- 2017-10-06
- Firm location
- Bridgewater, NJ, United States
Product description
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
Reason for recall
It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.
Data sourced from openFDA. This site is unofficial and independent of the FDA.