Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HydroSurg Plus Laparoscopic Irrigator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall HydroSurg Plus Laparoscopic Irrigator see related information
Date Initiated by Firm June 07, 2022
Create Date June 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-1304-2022
Recall Event ID 90377
510(K)Number K961492  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey
SmokEvac Trumpet Valve, Handle only, with Cojoined
Suction and Irrigation Tubing, Catalog number 0026880
Code Information UDI: (01)00801741010224(17)241028(10)JUFX2830 (01)00801741010224(17)241028(10)JUFY0743 Lots JUFX2830 JUFY0743
Recalling Firm/
Manufacturer		 Davol, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact North American Regional Complaint Center
844-823-5433
Manufacturer Reason
for Recall		 The product is not able to provide irrigation.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 4,780 (4,390 in US, 390 in Canada)
Distribution Worldwide distribution - US Nationwide and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = DAVOL, INC., SUB. C.R. BARD, INC.
-
-