[Recalled] SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB — Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be mor… | FD
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 | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB |
|---|---|
| Brand / manufacturer | LumiraDx |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1970-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 April 2023 |
| EAN / barcode | 00850027193205 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
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 LumiraDx
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.