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[Recalled] Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Med

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductMedtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part
Brand / manufacturerMedtronic Navigation, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-3055-2017
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date29 June 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

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 Medtronic Navigation, 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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