Stryker Neurovascular recalls Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00

Recalled October 16, 2019 · FDA recall Z-0065-2020 · Stryker Neurovascular

Hazard

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging · FDA Class II

Units

190 catheter guides

Sold at

OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland

Description

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

Product

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

Manufacturer(s)

Stryker Neurovascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →