Z-2378-2015 Class II Terminated
FDA device recall Z-2378-2015 was initiated by Boston Scientific Corporation on Jul 31, 2015 and is designated Class II. Reason for recall: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015. The recall status is terminated (terminated Feb 5, 2016). Affected quantity: total of 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 19, 2015
- Initiation Date
- Jul 31, 2015
- Termination Date
- Feb 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- total of 9 units
Product Description
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
Reason for Recall
AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
Distribution Pattern
Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
Code Information
162185 162318
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2378-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026