Recall Z-1305-2022 ยท GCJ Laparoscope, General & Plastic Surgery
Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
| Date | Jun 7, 2022 |
| Status | Open, Classified |
| Reason | The product is not able to provide irrigation. |
| Root cause | 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 | 4,780 (4,390 in US, 390 in Canada) |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 Davol Inc., Sub. C. R. Bard, Inc., May 15, 1996 |