Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1699-2016

January 29, 2016

Class II

Product summary

Firm
Valeant Pharmacueticals International
Event
Event 73678
Status
Terminated
Classification
Class II
Quantity
7,716
Official record key
device-enforcement:Z-1699-2016

Official wording

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.

Code information: Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.