Stradis Healthcare recalls TCTR Convenience Kits with potential pinhole leaks causing sterility breaches. Affected units have specific assembly numbers and lot numbers. Stop using if you own the kit.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling its TCTR Convenience Kit due to a risk of pinhole leaks in the outer bag near the seal. This could compromise the sterility of the kit, which is critical for medical use. The recall affects specific assembly numbers and lot numbers.
The outer bag may develop pinhole leaks near the seal, which could breach the sterility of the kit. This risk is specific to medical kits that require aseptic conditions for safe use. The leak could introduce contaminants into the kit.
Healthcare professionals using the TCTR Convenience Kit for medical procedures are most at risk. Patients receiving treatments with this kit could be affected if sterility is compromised.
Check for assembly number TCTR01, UDI-DI: M752TCTR011, and lot numbers starting with 222014334. The kit is sold by Stradis Healthcare.
Look for assembly number TCTR01, UDI-DI: M752TCTR011, and lot numbers starting with 222014334.
The outer bag may have pinhole leaks near the seal, which could breach the sterility of the kit.
Check for assembly number TCTR01, UDI-DI: M752TCTR011, and lot numbers starting with 222014334. If you have these details, contact Stradis Healthcare for further instructions.
The recall is for potential sterility breaches, which could affect medical procedures. However, the hazard does not explicitly mention serious injury risks.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0944-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0944-2023 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.
