Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON Acu...
Reason for Recall / 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
Product Description & Identification
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
Affected Products
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98277 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | 10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905 |
| Postal code | 60093-2753 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 511 |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251222 |
| Initial firm notification | Letter |
| Center classification date | 20260206 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionDistribution US nationwide.