| Date Initiated by Firm | February 11, 2022 |
|---|
| Create Date | April 20, 2022 |
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| Recall Status1 |
Terminated 3 on June 12, 2024 |
| Recall Number | Z-0960-2022 |
|---|
| Recall Event ID |
89580 |
| 510(K)Number | K201425 |
|---|
| Product Classification |
Transducer, ultrasonic, diagnostic - Product Code ITX
|
| Product | HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 |
|---|
| Code Information |
Lot Number: (10) 7842006001
UDI: (01) 05051968036537 (10) 784006001 (individual)
UDI: (01) 05051968036544 (10) 784006001 (box) |
Recalling Firm/
Manufacturer |
Huntleigh Healthcare Ltd.
35 Portmanmoor Road
Cardiff United Kingdom
|
| For Additional Information Contact |
44292048-5885 |
|---|
Manufacturer Reason
for Recall | Faceplate may become detached from the probe body. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | The firm notified their consignees by email beginning on 02/11/2022. The notice explained the issue and requested disposal of the probes on site. Distributors were directed to notify their customers. The firm will replace the affected probes. |
|---|
| Quantity in Commerce | 150 devices |
|---|
| Distribution | US Nationwide distribution in the states of OK, CA, GA, MI, VA. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = ITX
|
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