| Date Initiated by Firm | March 28, 2023 |
|---|
| Date Posted | May 17, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1601-2023 |
|---|
| Recall Event ID |
92114 |
| 510(K)Number | K210495 |
|---|
| Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
|
| Product | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR |
|---|
| Code Information |
Lot # 738182 ; UDI-DI: (01) 05051986013398 |
| FEI Number |
3002808173
|
Recalling Firm/
Manufacturer |
Surgical Innovations Ltd
6 Clayton Wood Bank
Lds
Leeds
United Kingdom
|
| For Additional Information Contact | Mrs. Sarah Howson
44 0 1132307597 |
|---|
Manufacturer Reason
for Recall | Optical Trocars sterility assurance can not be guaranteed |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | On March 29, 2023, Surgical Innovations issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. An update to the communication was sent on 4/17/2023 to affected consignees via E-Mail. In addition to informing consignees about the recall, Surgical Innovations ask consignees to take the following action:
1. Distributor should confirm receipt of this Field Safety Notice
2. Identify the devices held in stock at the distributor and quarantine affected batches awaiting further instruction.
3. Issue this Field Safety Notice to all end users (Hospital) that the distributor has supplied
4. All product still in stock at the end users must be returned to the distributor.
5. Confirmation must be obtained by the distributor that either all stock has been returned or that any other product has been successfully used.
6. Confirmation to Surgical Innovations using the attached form of this disposition of all stock
7. Await further instruction from Surgical Innovations regarding further action for the affected products. |
|---|
| Quantity in Commerce | 2380 units |
|---|
| Distribution | US: MA
OUS: None |
|---|
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = GCJ
|
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