Custom Assemblies…

Date

Dec. 29, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Stradis Medical, LLC dba Stradis Healthcare

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.

Distribution pattern

NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH

Quantity

620 tube sets

Codes and lots

Lot code 20519-2103

Recall started

Oct. 28, 2021

Device type

Set, Administration, Intravascular

Root cause (FDA)

Employee error

What the company told customers

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.

Recall number

Z-0400-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0400-2022. The agency record governs; check it and the company before acting.