Reported Oct 10, 2018 · Terminated
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used 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?
Dermacea Gauze Fluff Roll6 Ply4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m)
- REF 441103 Product UsageUsed as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds
- Lot codes and dates
- Lot Numbers
18D18066218E07036218E22236218F072362
- Lot Numbers
- 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.
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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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