Merit Medical Systems, Inc EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
Brand
Merit Medical Systems, Inc
Lot Codes / Batch Numbers
Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
Products Sold
Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
Merit Medical Systems, Inc is recalling EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain. due to Sterility of some units may be compromised due to damaged packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility of some units may be compromised due to damaged packaging.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.
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