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U.S. Department of Health and Human Services

Class 2 Device Recall Pressure Infusor Bag

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 Class 2 Device Recall Pressure Infusor Bagsee related information
Date Initiated by FirmSeptember 29, 2009
Date PostedDecember 14, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall NumberZ-0523-2010
Recall Event ID 53557
Product Classification Pressure Infusor Bag - Product Code KZD
ProductMerit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag CATALOG NUMBER PIB500 Used to apply pressure to a sealed bag of sterile fluid.
Code Information Lot #9H42824
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall
Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2
Other
ActionMerit 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.
Quantity in Commerce24 Infusor bags
DistributionUS (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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