United StatesReprocessed electrophysiology and ultrasound catheters sold by Medline Industries, LP identified as St. Jude Medical Response Diagnostic Electrophysiology Catheter, Item no. 401206RH (4‑electrode 10 mm) and Item no. 401305RH (10‑electrode 2‑5‑2 mm), Lot EP250203 (UDI‑DIs 10197344043767 and 10197344043637). They were recalled because specific lots may contain small particles of residual material on patient‑contacting surfaces. If used, those particulates could cause an inflammatory response or systemic infection and may produce granulomatous reaction or thrombus formation leading to cerebral or pulmonary embolism or deep vein thrombosis.
What's being recalled
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
The hazard
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)