[Recalled] SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1 — Busse Convenience kits contain one or more swab/swabstick drug products, manufa… | FDA 2022-02-22
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
| Product | SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1 |
|---|---|
| Brand / manufacturer | Busse Hospital Disposables, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1182-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 February 2022 |
| EAN / barcode | 00849233004719 |
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.