Device product

HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870

Z-1305-2022

June 07, 2022

Class II

Product summary

Firm: Davol, Inc.
Event: Event 90377
Status: Ongoing
Classification: Class II
Quantity: 4,780 (4,390 in US, 390 in Canada)
Official record key: device-enforcement:Z-1305-2022

Official wording

Reason: The product is not able to provide irrigation.

Code information: UDI: (01)00801741000362(17)241028(10)JUFY0738 (01)00801741000362(17)241028(10)JUFY0762 (01)00801741000362(17)241028(10)JUFY0746 (01)00801741000362(17)241028(10)JUFY0752 (01)00801741000362(17)241028(10)JUFY0758 (01)00801741000362(17)241028(10)JUFY0759 (01)00801741000362(17)241028(10)JUFY1655 Lots JUFY0738 JUFY0762 JUFY0746 JUFY0752 JUFY0758 JUFY0759 JUFY1655

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The product is not able to provide irrigation.