Non-sterile intravascular administration sets mistakenly distributed instead of sterile versions
Stradis Medical recalled non-sterile intravascular administration sets that were distributed in error. The devices should have been sterile and pose infection risk if used.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving non-sterile intravascular administration sets that should be sterile. While no illnesses or injuries have been reported, non-sterile intravascular devices pose significant infection risk due to their direct bloodstream access. Per the severity rubric, risk-of-harm medical devices without reported illness warrant a High (3) severity rating.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 620 non-sterile Custom Assemblies, Inc. Single Spike Tumescent Sets (Reorder Number CMS-1212NS) that were erroneously distributed to customers. These intravascular administration sets should have been sterile but were shipped as non-sterile products.
Non-sterile intravascular administration sets pose a serious infection risk if used. Intravascular administration sets are medical devices designed to deliver fluids and medications directly into the bloodstream. When non-sterile, they create a pathway for bacterial and other microbial contamination that can lead to bloodstream infections.
The affected products (Lot Code 20519-2103) were distributed to healthcare facilities in New Jersey, Michigan, Massachusetts, New York, Texas, Colorado, North Carolina, Connecticut, Oregon, and Ohio.
Healthcare facilities that received these products should stop using them immediately and contact Stradis Medical for instructions on returning or destroying the non-sterile sets. Patients who may have received treatment with these devices should consult with their healthcare provider.
The recalled product
- Product
- Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 620
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot code 20519-2103
Distribution
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