Recall Z-1457-2022— Davol, Inc.

Name: FDA recall Z-1457-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-27

Class II · Ongoing

Class II FDA medical device recall by Davol, Inc., initiated 2022-06-27. It names one FDA 510(k) clearance: K003790. Product: X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000). Reason: The device may potentially cause a fire, leading to a safety risk..

Recalling firm: Davol, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-27
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005Davol, Inc.·cleared 2000-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

Reason for recall

The device may potentially cause a fire, leading to a safety risk.

Data sourced from openFDA. This site is unofficial and independent of the FDA.