courtlistener_docket
1 records
CARROLL v. GENTELL, LLC
2026-04-21
Federal docket 2:26-cv-02617 (paed); matched party 'GENTELL, LLC'
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fda
11 records
FDA Recall: Gentell, Inc — Class II
20200408
During an FDA audit, it was discovered that the product was not properly registered with FDA. | Product: Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare pr...
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FDA Device Recall: Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing contain
2020-05-13
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Device Recall: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing contain
2020-05-13
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Device Recall: Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel a
2020-05-13
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Device Recall: Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of
2020-04-08
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Device Recall: Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a he
2020-04-08
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Device Recall: Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a
2020-04-08
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Device Recall: Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of
2020-04-08
Class II — During an FDA audit, it was discovered that the product was not properly registered with FDA.
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FDA Drug Recall: Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz -
2017-05-31
Class II — GMP Deviations; product may not meet cGMP requirements
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FDA Drug Recall: Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2
2017-01-11
Class II — CGMP Deviations
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FDA Drug Recall: Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114
2017-01-11
Class II — CGMP Deviations
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ny_corps
1 records
NY Corp: GENTELL, LLC
2024-10-09
FOREIGN LIMITED LIABILITY COMPANY | County: Albany | Jurisdiction: Pennsylvania
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