American Contract Systems, Inc. - Custom procedural convenience kits and trays - Class 2 Recall
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2024 Category: Medical Devices Source Type: alerts

American Contract Systems, Inc. - Custom procedural convenience kits and trays - Class 2 Recall
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2024 Category: Medical Devices Source Type: alerts

American Contract Systems, Inc. - Custom procedural convenience kits and trays - Class 2 Recall
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack, kit number RBCS12R; g) C-Section, kit number THCS49B; h) C-SECTION PACK (PS 020632), kit number UICS50AG; (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2024 Category: Medical Devices Source Type: alerts

American Contract Systems, Inc. - Custom procedural convenience kits and trays - Class 2 Recall
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2024 Category: Medical Devices Source Type: alerts

OBSTETRICAL TOWELETTE (benzalkonium chloride) cloth [Jianerkang Medical Co., Ltd]
Updated Date: Mon, 23 Oct 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 23, 2023 Category: Drugs & Pharmacology Source Type: alerts

GYNAZOLE 1 (butoconazole nitrate) cream [Padagis Israel Pharmaceuticals Ltd]
Updated Date: Mon, 05 Jun 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 5, 2023 Category: Drugs & Pharmacology Source Type: alerts

OBSTETRIX DHA COMBO PACK (docosahexaenoic acid, beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate) kit [Seyer Pharmatec, Inc.]
Updated Date: Tue, 28 Feb 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 28, 2023 Category: Drugs & Pharmacology Source Type: alerts

OBSTETRIX EC (beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate) tablet [Seyer Pharmatec, Inc.]
Updated Date: Fri, 24 Feb 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 24, 2023 Category: Drugs & Pharmacology Source Type: alerts

OBSTETRIX ONE (calcium ascorbate dihydrate, cholecalciferol, d-alpha tocopheryl acetate, pyridoxine hydrochloride, calcium l-5-methyltetrahydrofolate, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, docosahexaenoic acid) capsule, gelatin coated [Seyer Pharmatec, Inc.]
Updated Date: Fri, 24 Feb 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 24, 2023 Category: Drugs & Pharmacology Source Type: alerts

GE Medical Systems, LLC - Vivid S6 - Class 2 Recall
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - Vivid q - Class 2 Recall
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - Vivid i N - Class 2 Recall
Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - Vivid S6 N - Class 2 Recall
Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - Vivid S5 N - Class 2 Recall
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - Vivid q N - Class 2 Recall
Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts