Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(ND...
FDA Recall #D-0242-2017 — Class II — December 15, 2016
Product Description
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
Reason for Recall
CGMP Deviations
Recalling Firm
Gentell, Inc — Bristol, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,000 gauzes
Distribution
United States
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated