[Recalled] Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk — This recall has been initiated to address bulk packed, non-sterile Intravascula… | FDA 2021-10-28
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk |
|---|---|
| Brand / manufacturer | Stradis Medical, LLC dba Stradis Healthcare |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0400-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 28 October 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Stradis Medical, LLC dba Stradis Healthcare
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.