Recall Z-1791-2020 ยท DQX Wire, Guide, Catheter
Argon Medical Devices, Inc
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
| Date | May 7, 2020 (initiated Dec 4, 2019) |
| Status | Terminated |
| Reason | The stiffness of the soft end of the guidewire caused tissue perforation. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 1690 units |
| Distribution | No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160785 | Worker Guidewire Argon Medical Devices, Inc., Dec 8, 2016 |