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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 Recall
Pressure Infusor Bag
see related information
Date Posted December 14, 2009
Recall Status1 Terminated on December 15, 2009
Recall Number Z-0524-2010
Recall Event ID 53557
Product Classification Instrument, Manual, Surgical, General Use - Product Code MDM
Product Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM KIT
Code Information Lot #F726849
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan, Utah 84095
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action 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.
Quantity in Commerce 30 kits
Distribution US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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