54 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DRS·October 16, 2018
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·November 13, 2019
Triathlon MIS Femoral Adjustment Block;Catalog Number: 6541-5-601;Stryker Orthopaedics, Mahwah, New Jersey
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·September 19, 2006
Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·September 19, 2006
Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·September 19, 2006
Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
FDA Recall
Terminated
·Chad Therapeutics Inc·Product code BZD·March 25, 2005
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
FDA Enforcement
Class II
·Terminated·Associates of Cape Cod, Inc.·May 22, 2019
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
FDA Enforcement
Class II
·Terminated·WRP Asia Pacific Sdn Bhd·June 6, 2018
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
FDA Enforcement
Class II
·Terminated·Associates of Cape Cod, Inc.·September 28, 2022
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CDD·May 8, 2012
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CHH·December 15, 2014
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CAD·April 21, 2016
IMMULITE /IMMULITE 1000 Vitamin B12
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CDD·January 2, 2018