Smiths Medical recalls ENT Res 100ml Non-Sterile W Clamp & Female Luer (Product Code 68-2231-28) due to potential medication leakage from weakened weld joints. Affected units include specific lot numbers and UDI/DI codes.
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Smiths Medical is recalling ENT Res 100ml Non-Sterile W Clamp & Female Luer medical tubing because a production issue may cause medication leakage. This could lead to incorrect dosing if the tubing leaks during use.
A production equipment malfunction may create a weakened weld joint between the medication bag and tubing. This weakness could allow medication to leak, potentially causing incorrect dosing if the tubing is not properly sealed.
Healthcare professionals using this specific medical tubing for medication delivery are most at risk. Patients receiving treatment with this tubing could experience medication leakage.
Check for Product Code 68-2231-28, Lot Numbers 3997242-ENG through 4146021AB, or UDI/DI code 30610586044186 on the tubing packaging.
Look for Product Code 68-2231-28, Lot Numbers 3997242-ENG through 4146021AB, or UDI/DI code 30610586044186 on the tubing packaging.
Certain CADD Medication Cassette Reservoirs may have a weakened weld joint due to a production equipment malfunction, which could cause medication leakage.
Check for Product Code 68-2231-28, Lot Numbers 3997242-ENG through 4146021AB, or UDI/DI code 30610586044186 on the tubing packaging.
The recall record does not specify a remedy, so contact Smiths Medical for guidance on next steps.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0018-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0018-2025 from Smiths Medical. 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.