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Dragonfly OpStar imaging catheter by Abbott Medical

Recall date
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Brand

Dragonfly OpStar imaging catheter by Abbott Medical
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Lot code/Notes

REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO.

Model 1014651 - GTIN: (01)05415067031129 with these lot numbers: 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 with these lot numbers: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
Reason
Marker band farthest from the catheter tip (proximal marker) may become loose and, in two instances, has been observed to separate from the catheter while being used on a person.
Additional information