United StatesACUSON ACUNAV diagnostic ultrasound catheters (8FR) — Model ACU10135910 (“NOT FOR USE WITH SIEMENS SYSTEM”) and Model ACU10135936 (“FOR USE WITH SIEMENS SYSTEM”) — identified by GTIN/UDI 10888551004725 and 10888551004732 and the listed lot/serial numbers, sold in several U.S. states, are being recalled. Sterilmed says affected catheters were reprocessed beyond validated cycles, which may compromise sterility or mechanical integrity and can lead to severe adverse events such as infection, vascular injury, or embolism.
What's being recalled
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
Recalling firm: Sterilmed, Inc., Plymouth, MN, United States.
How to identify it
Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759 Lot Code: GTIN: 10888551004732 LOT# SERIAL#: 2188147 131065 2207154 916179 2220232 1050886 2234795 1170283
The hazard
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
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
United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
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)