107 results
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Sources: EU EUDAMED, US FDA
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Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
FDA Enforcement
Class II
·Terminated·Utah Medical Products, Inc·June 19, 2013
Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
FDA Recall
Terminated
·Utah Medical Products, Inc·Product code DRS·June 4, 2013
Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.
FDA Recall
Terminated
·Utah Medical Products, Inc·Product code HFN·June 16, 2008
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 Recall
Terminated
·Utah Medical Products, Inc·Product code KDD·October 16, 2015
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
Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·July 9, 2008
12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·July 9, 2008
10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·July 9, 2008
Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008
Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008
Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008
Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008
Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008
Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008
Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FPA·April 8, 2008