Z-1304-2022 Class II Ongoing
FDA device recall Z-1304-2022 was initiated by Davol, Inc. on June 7, 2022 and is designated Class II. Reason for recall: The product is not able to provide irrigation. The recall status is ongoing. Affected quantity: 4,780 (4,390 in US, 390 in Canada).
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- June 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,780 (4,390 in US, 390 in Canada)
Product Description
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
Reason for Recall
The product is not able to provide irrigation.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI: (01)00801741010224(17)241028(10)JUFX2830 (01)00801741010224(17)241028(10)JUFY0743 Lots JUFX2830 JUFY0743