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Sources: EU EUDAMED, US FDA
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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
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
FDA Recall
Open, Classified
·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021