Reprocessed imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Sterilmed Reprocessed Imaging Catheter, ACUSON CATHETER ACUNAV Diagnostic Ultrasound 8FR for use with Siemens systems, model ACU10135936, 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 4 units carrying GTIN 10888551004732, across lots including 2188147, 2207154 and 2220232. 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: 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…
- Manufacturer
- Sterilmed, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sterilmed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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