33 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
FDA Enforcement
Class II
·Terminated·Arrow International Inc·January 29, 2020
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·December 6, 2019
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Recall
Terminated
·TERRIFIC CARE LLC
61 Willet St
Bldg A-1, Fl 2
Passaic NJ 07055-1971·Product code GJS·December 20, 2018
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
FDA Recall
Terminated
·Gambro Renal Products, Incorporated·Product code FLD·July 18, 2014
Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437
FDA Recall
Terminated
·Clark Research and Development Inc Number·Product code FLD·January 19, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437
FDA Recall
Terminated
·Clark Research and Development Inc Number·Product code FLD·January 19, 2007
MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.
FDA Recall
Terminated
·Mesa Laboratories, Inc.·Product code FKH·May 12, 2017
Core Biopsy Tray Catalog Number: 8673R4
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FCH·February 22, 2022
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 175 mL, Clark Research and Development, Inc. Folsom, LA 70437
FDA Recall
Terminated
·Clark Research and Development Inc Number·Product code FLD·January 19, 2007
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FLD·December 21, 2017
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
FDA Recall
Terminated
·Gambro Renal Products, Incorporated·Product code FLD·July 18, 2014
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FCH·November 15, 2016
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, Clark Research and Development, Inc. Folsom, LA 70437
FDA Recall
Terminated
·Clark Research and Development Inc Number·Product code FLD·January 19, 2007
Stereo Breast Biopsy Tray Catalog Number: 2383R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FCH·February 22, 2022
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
FDA Recall
Terminated
·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015
Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model APS-21R - 2.1 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005
Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*EE12NLA - 1.2 m2 surface area, CL*EE15NLA - 1.5 m2 surface area and CL*EE20NLA - 2.0 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005
Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005