Merit Medical Systems, Inc StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.
Brand
Merit Medical Systems, Inc
Lot Codes / Batch Numbers
Lot numbers: 551268, 551537, 551615, 551616, 551702, 551703, 551704, 553104, 553360, 553361, 553362, 553363, 554362, 554367, 554368, 554483, 554497, 554504, 554505, 554506, 554723, 554764, 554765, 554766, 555638, 555639, 555655, 555656, 555657, 555658, 556406, 556407, 556408, 556409, 556410, 556411, 556842, 556843, 556844, 556845, 556846, 556847, 556871, 556872, 556873, 556874, 556875, 562518, 562748, 562874, 563254, 563255, 563388, 563389, 566538, 566899, 566900, 566901, 566902, 566903, 566904, 567248, 567515, 567596, 567599, 567600, 567601, 567767, 567835.
Products Sold
Lot numbers: 551268, 551537, 551615, 551616, 551702, 551703, 551704, 553104, 553360, 553361, 553362, 553363, 554362, 554367, 554368, 554483, 554497, 554504, 554505, 554506, 554723, 554764, 554765, 554766, 555638, 555639, 555655, 555656, 555657, 555658, 556406, 556407, 556408, 556409, 556410, 556411, 556842, 556843, 556844, 556845, 556846, 556847, 556871, 556872, 556873, 556874, 556875, 562518, 562748, 562874, 563254, 563255, 563388, 563389, 566538, 566899, 566900, 566901, 566902, 566903, 566904, 567248, 567515, 567596, 567599, 567600, 567601, 567767, 567835.
Merit Medical Systems, Inc is recalling StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Uno 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