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Terminated

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

FDA Recall Z-0400-2022 · Posted None

Recalling FirmStradis Medical, LLC dba Stradis Healthcare
Recall StatusTerminated
Product CodeFPA
Date Initiated2021-10-28
Date Terminated2023-08-07
Product Quantity620 tube sets

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993463INTRAVASCULAR ADMINISTRATION SETCustom Assemblies, Inc. · 2000-01-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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