Z-1601-2023 Class II Ongoing
FDA device recall Z-1601-2023 was initiated by Surgical Innovations Ltd on March 28, 2023 and is designated Class II. Reason for recall: Optical Trocars sterility assurance can not be guaranteed The recall status is ongoing. Affected quantity: 2380 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2380 units
Product Description
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Reason for Recall
Optical Trocars sterility assurance can not be guaranteed
Distribution Pattern
US: MA OUS: None
Code Information
Lot # 738182 ; UDI-DI: (01) 05051986013398