Recall Z-0533-2018 — 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids
U.S. FDA — Device Enforcement · United States · 2017-05-25 · Class II
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Reported risk: The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
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