37 results
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13ms
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Sources: EU EUDAMED, US FDA
Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Case Label: REORDER NO. 7501 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7501 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Urethral Catheter Tray With Plastic Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad. Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REORDER NO. 7500 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/o Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7500 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Urethral Catheter Tray Without Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7502 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Disposable Urethral Catheterization Tray With 14 French Red Rubber Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 14 French Red Rubber Catheter Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REORDER NO. 7504 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7504 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheter Tray With 30 mL Prefilled Syringe Including BZK Swabsticks nurse assist incorporated A6005, R1 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Lube Jelly 1200 mL Graduated Tray 30 mL Prefilled Syringe BZK Swabsticks Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REORDER NO. 7503 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7503 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheter Tray With 10 mL Prefilled Syringe Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Lube Jelly 1200 mL Graduated Tray 10 mL Prefilled Syringe BZK Swabsticks Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8155 Urethral Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
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
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
Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter 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: UT8145 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter 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. Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
FDA Recall
Terminated
·Teleflex Medical·Product code FCM·July 10, 2014
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
FDA Recall
Terminated
·Zavation·Product code NDN·March 25, 2021
Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations
FDA Recall
Terminated
·Apogee Medical, Inc·Product code OHR·March 24, 2011
Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.
FDA Recall
Terminated
·Cholestech Corp·Product code DCK·August 9, 2006
The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code DCK·March 6, 2013
TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DCK·December 5, 2003