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[Recalled] NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices — Sterility of device may be co

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductNEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Brand / manufacturerCodman & Shurtleff, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0865-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date11 January 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Sterility of device may be compromised due to lack of package integrity

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 Codman & Shurtleff, Inc.

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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