Date Initiated by Firm | June 07, 2022 |
Create Date | June 30, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1305-2022 |
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, 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 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
|