127 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Urethral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable Contents: 1-14 FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Pack of Lubricating Jelly, 1- Polylined Drape, 1-Graduated Tray, 1200 cc Reorder No. 37-232 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·January 20, 2011
Case Label: REORDER NO. 7200 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/o Catheter nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7200 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6033, R1 SINGLE USE WELCON BRAND Urethral Catheter Tray Without Catheter 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFree CONTENTS: CSR Wrap Waterproof Underpad Gloves Fenestrated Drape Forceps PVP Solution Rayon Balls in Prep Cup Specimen Container with ID Label Lube Jelly 1200 mL Graduated Drainage Tray Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·January 20, 2011
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 400-300 Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalog # 400-301 Imager" II Catheters Straight 5fr 65cm M0064003021 M0064003020 Catalog #400-302 Imager" II Catheters Bern 5fr 65cm M0064003031 M0064003030 Catalog #400-303 Imager" II Catheters JB1 5fr 65cm M0064003041 M0064003040 Catalog #400-304 Imager" II Catheters Straight 5fr 100cm M0064004021 M0064004020 Catalog #400-402 Imager" II Catheters Bern 5fr 100cm M0064004031 M0064004030 Catalog #400-403 Imager" II Catheters JB1 5fr 100cm M0064004041 M0064004040 Catalog #400-404 Imager" II Catheters Bern 5fr 40cm M0064005031 M0064005030 Catalog #400-503 The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOD·March 15, 2012
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
FDA Recall
Terminated
·COVIDIEN LLC·Product code KOD·July 11, 2018
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
FDA Recall
Terminated
·COVIDIEN LLC·Product code KOD·July 11, 2018
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code KOD·January 11, 2021
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614 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
Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Product Description and Material/UPN/Catalog Number Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) M0064003011 (outer box); Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner pouch) M0064003021 (outer box) and Imager" II Catheters Bern, 5Fr, 65cm M0064003030 (inner pouch) M0064003031 (outer box) The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOD·October 22, 2009
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc 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
Case Label: REF UT7015 Catheter Insertion Tray 10cc 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: UT7015 Catheter Insertion Tray 10 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 10 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
McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Urethral Catheter Tray with Red Rubber Catheter
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·September 2, 2011
WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter Caution: Contains Natural Latex 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Urethral Catheter Tray with Red Rubber Catheter
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·September 2, 2011
RUSCH, GB: Female Catheter, All Purpose PVC, 08 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
P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
FDA Recall
Terminated
·COVIDIEN LLC·Product code KOD·July 11, 2018
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - 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
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code KOD·June 3, 2025
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - 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
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - 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
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code KOD·December 4, 2023
REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·September 2, 2011