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[Recalled] Universal Nerve Block Tray Catalog Number: 9818 — Busse Convenience kits contain one or more swab/swabstick drug products, manufa… | FDA 2022-02-22

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductUniversal Nerve Block Tray Catalog Number: 9818
Brand / manufacturerBusse Hospital Disposables, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1162-2022
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date22 February 2022
EAN / barcode00849233012042

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

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 Busse Hospital Disposables, 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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