0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE E
FDA device recall Z-1791-2020 · posted 2020-05-07 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- The stiffness of the soft end of the guidewire caused tissue perforation.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 1690 units
- Distribution
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
- Date initiated
- 2019-12-04
- Date posted
- 2020-05-07
- Date terminated
- 2024-04-01
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Worker Guidewire (K160785) | Argon Medical Devices, Inc. | 2016-12-08 |