0.035"(.89mm)x80 cm guidewire recall
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Why was 0.035"(.89mm)x80 cm guidewire recalled?
The stiffness of the soft end of the guidewire caused tissue perforation.
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?
Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.
- Product
- 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 1690 units
- Distribution
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
- Recall date
- May 13, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)