YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
FDA device recall Z-1601-2023 · posted 2023-05-17 · Open, Classified
Recall details
- Recalling firm
- Surgical Innovations Ltd
- Reason for recall
- Optical Trocars sterility assurance can not be guaranteed
- Action taken
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 2380 units
- Distribution
- US: MA OUS: None
- Date initiated
- 2023-03-28
- Date posted
- 2023-05-17
- Location
- Leeds, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Port Access System (K210495) | Surgical Innovations Limited | 2021-06-18 |