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[Recalled] AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used wit

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductAngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus fro
Brand / manufacturerBoston Scientific Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2379-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date31 July 2015

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Boston Scientific Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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