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.
Reported: August 19, 2015 Initiated: July 31, 2015 #Z-2378-2015
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- total of 9 units
- Distribution
- Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: total of 9 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2015. Severity: Moderate. Recall number: Z-2378-2015.
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