30 results
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14ms
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Sources: EU EUDAMED, US FDA
Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code LJS·September 15, 2005
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
FDA Recall
Terminated
·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021
Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number: 73386 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item Number: 73386-01 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK Item Number: 73192 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK Item Number 73192 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code LFJ·January 21, 2015
Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.
FDA Recall
Terminated
·Tri-State Hospital Supply Corp·Product code HFX·April 12, 2005
Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
FDA Recall
Terminated
·Instrumed International, Inc.·Product code HFX·September 8, 2014
DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011
Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.
FDA Recall
Terminated
·Sandhill Scientific, Inc·Product code FFX·February 23, 2009
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code KFX·March 18, 2013
Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
FDA Recall
Terminated
·Surgical Design Inc·Product code HFX·January 26, 2011
Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code HFX·August 28, 2019
Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.
FDA Recall
Terminated
·Bock, Otto, Orthopedic Ind, Inc Two Carlson·Product code KFX·August 10, 2006
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code KFX·March 18, 2013
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code HFX·October 28, 2016