—#50531

Product

StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.

FDA product code: KMK — Device, Intravascular Catheter Securement
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: 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.

Why it was recalled

Sterility of some units may be compromised due to damaged packaging.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.

Recalling firm

Firm: Merit Medical Systems, Inc
Address: 1600 West Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Worldwide, including USA, France, Germany, and United Kingdom.

Timeline

Recall initiated: 2007-02-15
Posted by FDA: 2007-03-15
Terminated: 2011-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.