Atlas FDA

Merit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag CATALOG NUMBER PIB500 Used to a

FDA device recall Z-0523-2010 · posted 2009-12-14 · Terminated

Recall details

Recalling firm
Merit Medical Systems, Inc.
Reason for recall
Potential sterility breach caused by excessive shipment damage.
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.
Root cause
Other
Status
Terminated
Product code
KZD
Quantity affected
24 Infusor bags
Distribution
US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
Date initiated
2009-09-29
Date posted
2009-12-14
Date terminated
2009-12-15
Location
South Jordan, UT

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