Product Wiki · Recalls · U.S. FDA — Device Enforcement

Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number… — recall Z-1699-2016

U.S. FDA — Device Enforcement · United States · 2016-01-29 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1699-2016
Date of alert
2016-01-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Valeant Pharmacueticals International
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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