Reported Sep 21, 2022 · Ongoing

FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50…

Carwild Corporation

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: Carwild Corporation · 3 State Pier Rd · New London, CT · 06320-5817

Is this the product you have?

  • FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50
  • Pouches/Box Reorder Number34911510
Lot codes and dates
  • UDI-DIUnit
  • of Use00634303020740
  • Primary30634303020741
  • Lot Number22B0428
Amount recalled
90 CASES (4500 EACHES)

Where it was sold

  • Nationwide

Why it was recalled

Sterility with new cotton source not validated

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, 6:55 PM UTC

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