139 results · 26ms · Sources: EU EUDAMED, US FDA

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Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5) KIT ANGIO CSTM-PROVIDENCE , Pack Number SAMP0545

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FQM·April 8, 2024

SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

Vision Hollow Fiber Oxygenator with GBS Coating

FDA Recall
Terminated ·Gish Biomedical Inc·Product code DTZ·March 4, 2004

Vision Hollow Fiber Oxygenator

FDA Recall
Terminated ·Gish Biomedical Inc·March 31, 2003

PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

FDA Recall
Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula.

FDA Recall
Terminated ·Gish Biomedical Inc·Product code DTZ·November 28, 2005

The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.

FDA Recall
Terminated ·Gish Biomedical Inc·Product code DTZ·November 28, 2005

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DQO·March 3, 2026

LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FDE·May 20, 2014