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[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

recall fda device united-states

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

ProductSteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Brand / manufacturerLumiraDx
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1970-2023
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date25 April 2023
EAN / barcode00850027193205

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.

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