Reported Apr 8, 2020 · Ongoing
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell…
Gentell, Inc.
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: Gentell, Inc · 2701 Bartram Rd · Bristol, PA · 19007-6810
Is this the product you have?
- Gentell Hydrogel Ag 4x4, model no
- GEN-11420 - Product UsageUnder the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing
- Lot codes and dates
1134117110191811075181114918112111811277181131018113321811351181105919111881911214191124919
- Amount recalled
- 20,025
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
During an FDA audit, it was discovered that the product was not properly registered with FDA.
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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