0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
This recall has been terminated (originally issued May 7, 2020).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- December 4, 2019
- Posted
- May 7, 2020
- Terminated
- April 1, 2024
- Recall Number
- Z-1791-2020
- Quantity
- 1690 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The stiffness of the soft end of the guidewire caused tissue perforation.
Distribution
No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Lot / Code Info
Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.
Root Cause
Employee error
Action Taken
On 12/04/2019, the firm sent Medical Device Recall letter by email to their customer/ distributors. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form. Customers are instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible. Customers were also instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred.