Recall Z-1305-2022
Davol, Inc. · initiated June 7, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Codes / lots: 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
Reason for recall
The product is not able to provide irrigation.
FDA-determined 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.
Details
- Recall number
- Z-1305-2022
- Initiated
- June 7, 2022
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 4,780 (4,390 in US, 390 in Canada)
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Davol, Inc., Warwick, RI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1304-2022 Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle…The product is not able to provide irrigation. | 06/07/2022Open, Classified |