Non Siemens imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states over-reprocessing may compromise sterility or mechanical integrity, and no injuries are reported.
Plain-English summary
The ACUSON CATHETER ACUNAV Diagnostic Ultrasound 8FR, the variant not for use with Siemens systems, model ACU10135910, reprocessed by Sterilmed, is being recalled.
The affected catheters were reprocessed beyond validated cycles. Sterilmed states this may compromise device sterility or the mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
The recall covers 6 units carrying GTIN 10888551004725, across lots including 2196112 and 2200877. The product was distributed in Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas and Utah. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities holding affected units should quarantine them and follow Sterilmed's instructions.
The recalled product
- Product
- 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
- Manufacturer
- Sterilmed, Inc.
- Category
- Medical Device — Catheter
- Hazard
- over-reprocessed
- sterility-breach
- mechanical-integrity
- embolism-risk
Distribution
Distribution scope not specified by the agency.
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