269 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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VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code GQX·August 27, 2008
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GQX·May 29, 2012
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
FDA Enforcement
Class II
·Terminated·Utah Medical Products, Inc·November 18, 2015
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·May 28, 2014
HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". Sterile, single-use instrument for the application of two liquids.
FDA Recall
Terminated
·Haemacure Corporation·Product code KYZ·November 16, 2009
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
FDA Enforcement
Class II
·Terminated·Epimed International·November 15, 2017
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
FDA Enforcement
Class I
·Terminated·Tytek Medical Inc·February 19, 2020
Arrow central venous catheterization kit, 14 ga x 20 cm
FDA Recall
Terminated
·Arrow International Inc·Product code KZH·September 16, 2003
Arterial Catheterization Set
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·July 29, 2010
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
FDA Enforcement
Class II
·Terminated·Medisystems a NX Stage Company·January 30, 2013
Femoral Artery Catheterization Set
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·July 29, 2010
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
FDA Recall
Terminated
·Remington Medical Inc.·Product code KNW·February 15, 2005
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·July 29, 2010
Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·July 29, 2010
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·July 29, 2010
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·July 29, 2010
CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018
Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.
FDA Recall
Terminated
·Tri-State Hospital Supply Corp·Product code KZH·March 8, 2005