Recall Z-0627-2007

Merit Medical Systems, Inc · initiated February 15, 2007

Terminated

Product

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

Codes / lots: 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.

Reason for recall

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

FDA-determined cause: Other

Action taken

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

Details

Recall number
Z-0627-2007
Initiated
February 15, 2007
Posted by FDA
March 15, 2007
Terminated
November 9, 2011
Product code
KMK – Device, Intravascular Catheter Securement
Quantity
195,001 units
Distribution
Worldwide, including USA, France, Germany, and United Kingdom.
Recalling firm
Merit Medical Systems, Inc, South Jordan, UT

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0628-2007 StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit…Sterility of some units may be compromised due to damaged packaging. 02/15/2007Terminated
Z-0629-2007 EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.Sterility of some units may be compromised due to damaged packaging. 02/15/2007Terminated