Class 2 Device Recall Single Spike Tumescent Set w/o Chamber

• Date Initiated by Firm: October 28, 2021
• Create Date: December 20, 2021
• Recall Status: Terminated on August 07, 2023
• Recall Number: Z-0400-2022
• Recall Event ID: 89046
• 510(K)Number: K993463
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
• Code Information: Lot code 20519-2103
• Recalling Firm/ Manufacturer: Stradis Medical, LLC dba Stradis Healthcare; 3025 Northwoods Pkwy; Peachtree Corners GA 30071-1524
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: Stradis Healthcare immediately contacted all 28 customers via email and/or phone between 10/28/21 and 10/29/21. The firm has requested the return of the units.
• Quantity in Commerce: 620 tube sets
• Distribution: NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA and Original Applicant = CUSTOM ASSEMBLIES, INC.