Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for
FDA device recall Z-0745-2010 · posted 2010-01-29 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- A manufacturing defect may prevent adequate sterilization of the entire device.
- Action taken
- Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm. For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OEZ
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution -- United States ( PA and TX) and Japan.
- Date initiated
- 2009-01-29
- Date posted
- 2010-01-29
- Date terminated
- 2011-06-16
- Location
- South Jordan, UT
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