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    Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.

    FDA Recall
    Terminated ·Cook Inc.·Product code LJE·August 31, 2020

    X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code LJE·October 12, 2016

    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJE·May 28, 2013

    Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LJE·August 5, 2025

    Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649

    FDA Recall
    Terminated ·Cook Inc.·Product code LJE·January 4, 2019

    Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

    FDA Recall
    Open, Classified ·Cook Inc.·Product code LJE·October 13, 2021

    Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LJE·October 17, 2025

    NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJE·May 28, 2013

    Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code LJE·April 11, 2007

    UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

    FDA Recall
    Terminated ·Cook Inc.·Product code LJE·January 27, 2016

    Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock.

    FDA Recall
    Terminated ·Cook Inc.·Product code LJE·August 31, 2020

    Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.

    FDA Recall
    Terminated ·Cook Inc.·Product code LJE·January 27, 2016

    Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123 COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123 KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 Product Usage: custom dialysis prep kits

    FDA Recall
    Terminated ·Lee Medical International Inc·Product code FKG·March 22, 2011

    Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc. Franklin, TN; Reorder CVI1025.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corporation·Product code LRS·January 14, 2009

    Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code GNB·November 30, 2007

    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020

    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020

    Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·November 7, 2005

    Material CVI3015, ADULT PICC INSERTION TRAY, MANUFACTURED FOR LEE MEDICAL INC, 2550 Meridian Blvd. " Suite 200 " Franklin, TN 37067, REORDER CVI3015, STERILE FACILITATES PICC LINE PLACEMENT

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code LRS·March 31, 2011