HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
This recall is currently active, issued June 7, 2022. It was issued by Davol, Inc..
- Company
- Davol, Inc.
- Recall Initiated
- June 7, 2022
- Recall Number
- Z-1305-2022
- Quantity
- 4,780 (4,390 in US, 390 in Canada)
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
Reason for Recall
The product is not able to provide irrigation.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
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
Root Cause
Under Investigation by firm
Action Taken
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.