LumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Cata…

Recall date

April 25, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1970-2023

FDA classification

Class II

Brand / firm

LumiraDx

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB