Smiths Medical recalls Gang Cath Lab Set Model M20858R1 due to potential insufficient welds in stopcocks and manifolds, which could cause leaks or disconnections during IV fluid administration.
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Smiths Medical is recalling Gang Cath Lab Sets with model number M208:58R1 because some stopcocks and manifolds may have insufficient or incomplete welds. This could lead to leaks or disconnections during IV fluid administration, potentially causing injury.
Insufficient or incomplete welds in stopcocks and manifolds could cause leaks or disconnections during IV fluid administration. This might lead to fluid leakage, improper flow control, or potential injury to the patient.
Healthcare professionals using the Gang Cath Lab Set for IV fluid administration are most at risk. Patients receiving IV fluids through this device could be affected if the stopcocks or manifolds fail.
Check for the model number M20858R1 on the Gang Cath Lab Set. The affected lot number is 4007165.
Verify the lot number on the device; affected units have lot number 4007165.
The model number is M20858R1.
Lot number 4007165 is affected.
Some stopcocks and manifolds may have insufficient or incomplete welds, which could cause leaks or disconnections during IV fluid administration.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1474-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1474-2021 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.
