HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irr
Summary
The FDA issued a Class II for HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve by Davol, Inc.. Reason: The product is not able to provide irrigation..
Details
Source
Device Recall
External ID
Z-1305-2022
Action Date
2022-07-06
Status
Ongoing
Category
device
Product Description
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Lot/Code Info: 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
Quantity Affected: 4,780 (4,390 in US, 390 in Canada)
Reason for Recall
The product is not able to provide irrigation.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-07
Company
Warwick, RI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Davol, Inc. has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Davol, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Davol, Inc. have FDA actions?
Davol, Inc. has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1305-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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