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U.S. Department of Health and Human Services

Class 2 Device Recall HydroSurg Plus Laparoscopic Irrigator

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 Class 2 Device Recall HydroSurg Plus Laparoscopic Irrigatorsee related information
Date Initiated by FirmJune 07, 2022
Create DateJune 30, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1305-2022
Recall Event ID 90377
510(K)NumberK961492 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductHydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
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
Recalling Firm/
Manufacturer		 Davol, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information ContactNorth 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
ActionOn 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 Commerce4,780 (4,390 in US, 390 in Canada)
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GCJ
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