Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0400-2022 — Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

U.S. FDA — Device Enforcement · United States · 2021-10-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0400-2022
Date of alert
2021-10-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stradis Medical, LLC dba Stradis Healthcare
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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