127 results · 17ms · Sources: EU EUDAMED, US FDA

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Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

FDA Recall
Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

FDA Recall
Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

FDA Recall
Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

FDA Recall
Terminated ·C.R. Bard, Inc., Urological Division·Product code KOD·September 7, 2012

Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

FDA Recall
Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

FDA Recall
Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

FDA Recall
Terminated ·Teleflex Medical·Product code KOD·September 4, 2014

Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT7035 Catheter Insertion Tray 30 cc Pre-Filled Syringe with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 30 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.

FDA Recall
Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

FDA Recall
Terminated ·Covidien Llc·Product code KOD·April 30, 2020

HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

FDA Recall
Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

FDA Recall
Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

FDA Recall
Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

FDA Recall
Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.

FDA Recall
Terminated ·C.R. Bard, Inc.·Product code KOD·July 7, 2015

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

FDA Recall
Terminated ·C.R. Bard, Inc.·Product code KOD·July 7, 2015

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.

FDA Recall
Terminated ·C.R. Bard, Inc.·Product code KOD·July 7, 2015

Rusch EasyCath Kit

FDA Recall
Terminated ·Teleflex Medical·Product code KOD·July 1, 2019

Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

FDA Recall
Terminated ·Covidien Llc·Product code KOD·April 30, 2020

TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T

FDA Recall
Terminated ·COVIDIEN LLC·Product code KOD·July 11, 2018

RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.

FDA Recall
Terminated ·Teleflex Medical·Product code KOD·June 30, 2011