57 results
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18ms
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Sources: EU EUDAMED, US FDA
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
FDA Recall
Open, Classified
·Agilent Technologies, Inc.·Product code PFX·March 20, 2025
CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan Dx Pre-PCR (-20C) MOD T E W, CytoScan Dx Pre-PCR (2-8C) MOD F L H, CytoScan Dx Post-PCR (-20C) MOD S AH W PB, CytoScan Dx Post-PCR (2-8C) MOD E PW, CytoScan Dx Post-PCR (15- 30 C) CytoScan Dx WS A CytoScan Dx WS B CytoScan Dx Array kit, 6Pk ChAS Dx Analysis Software and Browser
FDA Recall
Terminated
·Affymetrix Inc·Product code PFX·April 14, 2016
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
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
FDA Recall
Terminated
·Pfm Medical Inc·Product code LJS·October 20, 2014
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
FDA Recall
Terminated
·Pfm Medical Inc·Product code GCB·October 20, 2014
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
FDA Recall
Open, Classified
·PFM MEDICAL INC.·Product code DXE·April 21, 2026
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
FDA Recall
Terminated
·Pfm Medical Inc·Product code DWM·October 20, 2014
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
FDA Recall
Terminated
·Pfm Medical Inc·Product code DWM·October 20, 2014
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
FDA Recall
Terminated
·Pfm Medical Inc·Product code FJS·October 20, 2014
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
FDA Recall
Terminated
·Pfm Medical Inc·Product code GCB·October 20, 2014
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
FDA Recall
Terminated
·Pfm Medical Inc·Product code GCB·October 20, 2014
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.
FDA Recall
Terminated
·Pfm Medical Inc·Product code LJS·October 20, 2014
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
FDA Recall
Terminated
·Pfm Medical Inc·Product code LJS·October 20, 2014
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DQO·March 3, 2026
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, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 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
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code DRE·January 30, 2024
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