Reported May 25, 2022 · Ongoing
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Abbott Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
Dragonfly OpStar Imaging CatheterREF 1014651/10146520.068 in0.014 in135 cmSTERILE EO
- Lot codes and dates
- Model 1014651 - GTIN(01)05415067031129 Lot #:8127930, 8211506, 8127931, 8211507, 8127932, 8220671, 8127934, 8220672, 8131366, 8220673, 8131367, 8220675, 8131369, 8257085, 8131370, 8257087, 8147186, 8274128 8147188, 8294077
80100278147191801004381538158010047815381680100528211505
- Model 1014652 - GTIN
(01) 05415067031112 Lot #:811164481927968131360821150881313618211509813136282115108131363 821151181313648211512813136582115138157505821151481575068211515 818497982115168184980821151781849818211518818498282115198185100 821152081851018211521819278282206808192783822068181927848220684819278682206858192787822068681927888256952819278982569538192791 82569548192793827413381927958294003
- Model 1014651 - GTIN(01)05415067031129 Lot #:
- Amount recalled
- 14,544 UNITS
Where it was sold
Why it was recalled
Stop using this product now
There is a potential that the proximal marker may separate from the imaging catheter
Using this product could cause serious injury, illness or death — stop using it now.
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