Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- October 25, 2010
- Posted
- December 8, 2010
- Terminated
- March 23, 2012
- Recall Number
- Z-0552-2011
- Quantity
- 124 units
- Firm Location
- South Jordan, UT
Reason for Recall
Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Distribution
Nationwide Distribution in the states of CA, IL, IN, and UT.
Lot / Code Info
Lot No.: F666483, F699603, F731843, F749946, F772431, H110055, H110818, H176455
Root Cause
Process control
Action Taken
Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.