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[Recalled] UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S — Use of the impacted product may cause a superficial infection requiring PO anti… | FDA

recall fda device france

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

Recall details

ProductUNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
Brand / manufacturerNewDeal SA
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2443-2018
Country of noticeFrance
Risk levelClass II
Hazard typerecall
Notice date22 May 2018

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

This Class II recall concerns device products distributed in France 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 NewDeal SA

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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