Recall Z-0209-2026— Cardinal Health 200, LLC

Name: FDA recall Z-0209-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-18

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2025-09-18. It names one FDA 510(k) clearance: K851444. Product: Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve. Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-18
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K851444 — KEITH-A.R.V.Karl M. Block Co.·cleared 1985-05-10

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

Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve

Reason for recall

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

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