Z-1699-2016 Class II Terminated
FDA device recall Z-1699-2016 was initiated by Valeant Pharmacueticals International on January 29, 2016 and is designated Class II. 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. The recall status is terminated (terminated October 6, 2017). Affected quantity: 7,716.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2016
- Initiation Date
- January 29, 2016
- Termination Date
- October 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,716
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.
Distribution Pattern
Nationwide Distribution
Code Information
Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757