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Sources: EU EUDAMED, US FDA
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O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 16KPES SIZE:16Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 16KPES Product No: AAM 8016KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.
FDA Recall
Terminated
·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·February 11, 2009
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·November 24, 2009
BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FOZ·October 19, 2009
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, C-SDLMY-401J-ABRM-IHI-FST, G48047, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/5 cm, C-UDLMY-401J- PED-ABRM-HC-FST, G43992, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm, C-UDLMY-801J-ABRM-HC-FST-A, G50819, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 7.5Fr/20cm, CUDLMY751JRSCABRMFST, G13482, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, C-UDLMY-401J-PED-ABRM-HC-IHI-FST, G48059, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, C-UDLMY-801J-MNP-ABRM-HC-FST-A, G44069, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm, CUTLMY501JRSCCCT, G26945, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm, C-UDLMY-401J-CCT, G26927, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-ABRM-HC-FST-RD, G47832, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/5 cm, CUDLMY501JPED- ABRM-HC-FST, G43982, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·July 29, 2010
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
FDA Recall
Terminated
·Bard Access Systems·Product code FOZ·August 8, 2014
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
FDA Recall
Open, Classified
·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
FDA Recall
Open, Classified
·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021