Reported May 24, 2017 · Terminated
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
ReFlow Medical
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: ReFlow Medical · 1003 Calle Sombra · San Clemente, CA · 92673-6244
Is this the product you have?
Wingman 35 Crossing Catheter65cm
- Model NumbersWGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Product as published — Lot Numbers WGM35065US1508074, 1509154R, 1510204, 1510054R, 1602164,1604194R,1605133, 1606273R2, 1701244. WGM35090US1502053, 1505144,1508264R, 1508265,1601044,1603024,1603214, 1605193, 1606304, 1610314. WGM35135US1503094, 1505061, 1506104, 1508204R, 1508205, 1510074R, 1511304, 1512174,1512174R, 1602174, 1604213, 1604253, 1605113, 1606203, 1611034. WGM35065CE1508074R, 150874R1, 1509154, 1510024, 1510024R, 1510054, 1602164R, 1604194, 1606273, 1606273R. WGM35090CE1502053R, 1505144R, 1505144R1, 1505144R2, 1505144R3, 1508264, 1601044R, 1603024R, 1603024R2, 1603214R, 1603214R2, 1605194, 1605194R, 1605194R2. WGM35135CE1503094R, 1503094R1, 1503094R2, 1505061R, 1505264, 1506104R, 1508204, 1508205R, 1510074, 1602174R, 1604213R, 1606203R, 1606203R2, 1606204, 1606204R, 1611114. - Amount recalled
- 2,794 units
Where it was sold
Why it was recalled
Stop using this product now
ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
Using this product could cause serious injury, illness or death — stop using it now.
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