Reported Oct 10, 2018 · Terminated

Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and…

Covidien LLC

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: COVIDIEN LLC · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

    • Dermacea Gauze Fluff Roll
    • 6 Ply
    • 4 x 4-1/8 yd (10.2 cm x 3.7 m)
  • REF 441106 Product UsageUsed as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds
Lot codes and dates
  • Lot Numbers
    • 18D180762
    • 18D180862
    • 18E029062
    • 18E029162
    • 18E029262
    • 18E029362
    • 18E070662
    • 18E070462
    • 18E070562
    • 18E130962
    • 18E131062
    • 18E166462
    • 18E166562
    • 18E131162
    • 18E222562
    • 18E222462
    • 18F034562
    • 18F034462
    • 18F034362
    • 18F072562
    • 18F072462
    • 18F122462
    • 18F122362
Amount recalled
2,730,821 units in total

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential for product sterility breach due to a compromised or pinched seal defect

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 3, 2020 · Data as of Sep 19, 6:52 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.