Reported Jan 11, 2017 · Terminated
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28),…
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 Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28)
- Manufactured byGentell, 2701 Bartram Road, Bristol, PA 19007
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 1121615, 1121713, 1122215 2 Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515 3 Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615 4 Exp. 11/18 - Amount recalled
- 3,000 gauzes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
CGMP Deviations
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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