Recall Z-1457-2022 ยท GCJ Laparoscope, General & Plastic Surgery
Davol, Inc.
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
| Date | Jun 27, 2022 |
| Status | Open, Classified |
| Reason | The device may potentially cause a fire, leading to a safety risk. |
| Root cause | Under Investigation by firm |
| Action | On June 27, 2022, the firm notified customers of the recall through Urgent Medical Device Recall letters. Customers were instructed to immediately identify and destroy all remaining product in your possession. BD will issue credit to customers who purchased the product from BD. If the customer purchased the product from a Distributor, contact your distributor for further instructions and credit resolution. If you have further questions about this recall, contact the firm: Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com |
| Quantity | 9420 (9337 in US; 83 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 Davol, Inc., Dec 22, 2000 |