Gentell Hydrogel Ag Saturated Gauze Recalled for CGMP Deviations
Gentell, Inc. is voluntarily recalling 3,000 units of Hydrogel Ag Saturated Gauze in three sizes due to Current Good Manufacturing Practice (CGMP) deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or structural defect.
Plain-English summary
Gentell, Inc. is voluntarily recalling 3,000 units of Gentell Hydrogel Ag Saturated Gauze in 2"x2", 4"x4", and 4"x8" sizes. The recall was initiated on December 15, 2016, and was classified as Class II by the FDA on January 2, 2017. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.
The affected products are distributed in the United States. Specific lot numbers and expiration dates are listed in the recall details: 2"x2" lots 1121615, 1121713, and 1122215; 4"x4" lots 1123315, 1125215, and 1126515; and 4"x8" lots 1127315, 1130015, and 1133615, all with an expiration date of 11/18.
The recall was initiated by the firm and is voluntary. The recall status is terminated as of February 16, 2018. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products if found.
The recalled product
- Product
- Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 3,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615
- 1121713
- 1122215
- Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315
- 1125215
- 1126515
- Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315
- 1130015
- 1133615
- Exp. 11/18
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Gentell, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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