Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for inflation and deflation of interventional devices
This recall has been terminated (originally issued December 14, 2009).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- September 29, 2009
- Posted
- December 14, 2009
- Terminated
- December 15, 2009
- Recall Number
- Z-0513-2010
- Quantity
- 20 inflation syringes
- Firm Location
- Jordan, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential sterility breach caused by excessive shipment damage.
Distribution
US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
Lot / Code Info
Lot number: F730934
Root Cause
Other
Action Taken
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
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