Medline Industries, LP: Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
- Reason / hazard
- These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Distribution US nationwide.
- Recall initiated
- 2025-12-22
- Code info
- 10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
- Product quantity
- 94
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98277
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