Merit Medical Systems, Inc. Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Lot Number F580867
Products Sold
Lot Number F580867
Merit Medical Systems, Inc. is recalling Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84 due to Convenience kits may be non-sterile due to inadequate package sealing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Convenience kits may be non-sterile due to inadequate package sealing.
Recommended Action
Per FDA guidance
Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.
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 noticeDistribution
As reported by FDA
MO, OR
Page updated: Jan 10, 2026