Z-0400-2022Class II

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

Name: Z-0400-2022 Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Creator: Stradis Medical, LLC dba Stradis Healthcare
Published: 2021-10-28
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2021-10-28 / Terminated / root cause: manufacturing process

FDA source

Stradis Medical, LLC dba Stradis Healthcare began a recall of Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk on 2021-10-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0400-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-28
Posted: 2021-12-20
Terminated: 2023-08-07
Recalling firm: Gyn-Disposables, Inc.
Product: Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: Lot code 20519-2103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0400-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0400-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20

Product code FPA

K993463Class IIIntravascular Administration SetCustom Assemblies, Inc. / cleared 2000-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)