Reported Jun 21, 2023 · Ongoing

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

LumiraDx

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LumiraDx · 221 Crescent St · Waltham, MA · 02453-3475

Is this the product you have?

  • SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area
  • Catalog Number60566RevB
Lot codes and dates
  • GTIN-DI00850027193205
  • Pack Lot Number85438
  • Individual Swab Lot Number86445
  • Exp Date28-Oct-2023
Amount recalled
1003 kits

Where it was sold

  • Nationwide

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.