Stradis Healthcare recalls bulk non-sterile Custom Assemblies Single Spike Tumescent Set (Reorder CMS-1212NS) due to incorrect distribution. This poses infection risk if used for sterile procedures.
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.
Stradis Healthcare is recalling bulk packs of Custom Assemblies Single Spike Tumescent Set (Reorder CMS-1212NS) because they were mistakenly distributed as non-sterile when sterile versions were ordered. Using these sets for sterile medical procedures could lead to infections.
The sets were distributed without proper sterilization, meaning they could carry contaminants. When used for sterile medical procedures, this increases infection risk for patients and staff.
Healthcare professionals who ordered this specific bulk set for sterile procedures may be affected. Patients receiving procedures using these sets face infection risks.
Check for the Reorder Number CMS-1212NS on the product label. The bulk set was sold with Lot code 20519-2103.
Look for the Reorder Number CMS-1212NS and Lot code 20519-2103 on the set.
The sets were mistakenly distributed as non-sterile when sterile versions were ordered for medical procedures.
Using non-sterile sets for sterile procedures could lead to infections.
Check for the Reorder Number CMS-1212NS and Lot code 20519-2103 on the product label.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0400-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0400-2022 from Stradis Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
