Recall Z-1304-2022— Davol, Inc.

Name: FDA recall Z-1304-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-07

Class II · Ongoing

Class II FDA medical device recall by Davol, Inc., initiated 2022-06-07. It names one FDA 510(k) clearance: K961492. Product: HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880. Reason: The product is not able to provide irrigation..

Recalling firm: Davol, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-07
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K961492 — HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010Davol Inc., Sub. C. R. Bard, Inc.·cleared 1996-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.