Wingman 35 Crossing Catheter recall
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
Why was Wingman 35 Crossing Catheter recalled?
ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers Model number: WGM35065US 1508074, 1509154R, 1510204, 1510054R, 1602164,1604194R,1605133, 1606273R2, 1701244. Model number: WGM35090US 1502053, 1505144,1508264R, 1508265,1601044,1603024,1603214, 1605193, 1606304, 1610314. Model number: WGM35135US 1503094, 1505061, 1506104, 1508204R, 1508205, 1510074R, 1511304, 1512174,1512174R, 1602174, 1604213, 1604253, 1605113, 1606203, 1611034. Model No. WGM35065CE 1508074R, 150874R1, 1509154, 1510024, 1510024R, 1510054, 1602164R, 1604194, 1606273, 1606273R. Model No. WGM35090CE 1502053R, 1505144R, 1505144R1, 1505144R2, 1505144R3, 1508264, 1601044R, 1603024R, 1603024R2, 1603214R, 1603214R2, 1605194, 1605194R, 1605194R2. Model No. WGM35135CE 1503094R, 1503094R1, 1503094R2, 1505061R, 1505264, 1506104R, 1508204, 1508205R, 1510074, 1602174R, 1604213R, 1606203R, 1606203R2, 1606204, 1606204R, 1611114.
- Product
- Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
- Recalling firm
- ReFlow Medical
- Quantity
- 2,794 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.
- Recall date
- May 24, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)