Reported Oct 10, 2018 · Terminated

Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary…

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?

  • Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Lot codes and dates
  • Lot Numbers
    • 18D180962
    • 18D181062
    • 18E029462
    • 18E029562
    • 18E070762
    • 18E131262
    • 18E131362
    • 18E131462
    • 18E166662
    • 18E167362
    • 18E223462
    • 18E223362
    • 18F054362
    • 18E222662
    • 18F034762
    • 18F034662
    • 18F035562
    • 18F072862
    • 18F072662
    • 18F072962
    • 18F123062
    • 18F122562
    • 18F122662
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, 5:38 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.