Recall Z-0400-2022— Stradis Medical, LLC dba Stradis Healthcare

Name: FDA recall Z-0400-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-28

Class II · Terminated

Class II FDA medical device recall by Stradis Medical, LLC dba Stradis Healthcare, initiated 2021-10-28, terminated 2023-08-07. It names one FDA 510(k) clearance: K993463. Product: Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk. Reason: This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set..

Recalling firm: Stradis Medical, LLC dba Stradis Healthcare
Classification: Class II
Status: Terminated
Initiated: 2021-10-28
Terminated: 2023-08-07
Firm location: Peachtree Corners, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K993463 — INTRAVASCULAR ADMINISTRATION SETCustom Assemblies, Inc.·cleared 2000-01-04

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

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Reason for recall

This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

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