Merit Medical Systems, Inc. Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Lot number: V553545
Products Sold
Lot number: V553545
Merit Medical Systems, Inc. is recalling Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical Systems, Inc., 160 due to A manufacturing defect may prevent adequate sterilization of the entire device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A manufacturing defect may prevent adequate sterilization of the entire device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026