Home / Recalls / Gentell, Inc / D-0242-2017

D-0242-2017 Class II Terminated

Recalled by Gentell, Inc — Bristol, PA

Recall Details

Product Type
Drugs
Report Date
January 11, 2017
Initiation Date
December 15, 2016
Termination Date
February 16, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,000 gauzes

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

Distribution Pattern

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

Other recalls by Gentell, Inc

  • Z-1907-2020 Class II — Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing contain (March 26, 2020)
  • Z-1910-2020 Class II — Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel a (March 26, 2020)
  • Z-1909-2020 Class II — Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing contain (March 26, 2020)
  • Z-1908-2020 Class II — Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing contain (March 26, 2020)
  • Z-1625-2020 Class II — Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of (February 27, 2020)
  • Z-1624-2020 Class II — Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of (February 27, 2020)
  • Z-1626-2020 Class II — Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a he (February 27, 2020)
  • Z-1623-2020 Class II — Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a (February 27, 2020)
  • D-0866-2017 Class II — Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - (April 19, 2017)
  • D-0243-2017 Class II — Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2 (December 15, 2016)