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Open, Classified

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

FDA Recall Z-1305-2022 · Posted None

Recalling FirmDavol, Inc.
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2022-06-07
Product Quantity4,780 (4,390 in US, 390 in Canada)

Reason for Recall

The product is not able to provide irrigation.

Firm Action

On June 7, 2022, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were instructed to destroy all affected product remaining in their possession.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961492HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010Davol Inc., Sub. C. R. Bard, Inc. · 1996-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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