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Recall Observatory FDA recall evidence

Device product

HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880

Z-1304-2022

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-1304-2022

Official wording

Reason: The product is not able to provide irrigation.

Code information: UDI: (01)00801741010224(17)241028(10)JUFX2830 (01)00801741010224(17)241028(10)JUFY0743 Lots JUFX2830 JUFY0743

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.