Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Summary
The FDA issued a Class II for Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number by Stradis Medical, LLC dba Stradis Healthcare. Reason: This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders .
Details
Source
Device Recall
External ID
Z-0400-2022
Action Date
2021-12-29
Status
Terminated
Category
device
Product Description
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Lot/Code Info: Lot code 20519-2103
Quantity Affected: 620 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.
Distribution
NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-28
Company
Peachtree Corners, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stradis Medical, LLC dba Stradis Healthcare has 93 FDA actions in our database, including 93 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stradis Medical, LLC dba Stradis Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stradis Medical, LLC dba Stradis Healthcare have FDA actions?
Stradis Medical, LLC dba Stradis Healthcare has 93 FDA actions in our database, including 93 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0400-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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