Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

Reason: There is a potential that the proximal marker may separate from the imaging catheter

Code information: Model 1014651 - GTIN: (01)05415067031129 Lot #: 8010027 8147191 8010043 8153815 8010047 8153816 8010052 8211505 8127930, 8211506, 8127931, 8211507, 8127932, 8220671, 8127934, 8220672, 8131366, 8220673, 8131367, 8220675, 8131369, 8257085, 8131370, 8257087, 8147186, 8274128 8147188, 8294077 Model 1014652 - GTIN: (01) 05415067031112 Lot #:8111644, 8192796, 8131360, 8211508, 8131361, 8211509, 8131362, 8211510,8131363 8211511, 8131364, 8211512, 8131365, 8211513, 8157505, 8211514, 8157506, 8211515 8184979, 8211516, 8184980, 8211517, 8184981, 8211518, 8184982, 8211519, 8185100 8211520, 8185101, 8211521, 8192782, 8220680, 8192783, 8220681, 8192784, 8220684, 8192786, 8220685, 8192787, 8220686, 8192788, 8256952, 8192789, 8256953, 8192791 8256954, 8192793, 8274133, 8192795, 8294003

Distribution pattern: US:AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD ME MI MN MO MT NC NE NH NJ NM NV NY OH OK OR PA PR RI SC TN TX UT VA VT WA WI, PR OUS: AE, AT, AW, BE, CA, CH, DE, DK, IT, JP, LU, NL, NO, NZ, PL, EE, ES, FI, FR, GB, HK, HU, IE, PT, RO, SE, SG, SI, TH