Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 88 of 138
ConMed Corporation
Class II Terminated
STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length,...
Reason: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Z-0805-2018 March 7, 2018 Utica, NY
Angiodynamics, Inc.
Class II Terminated
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is ...
Reason: Product was placed into distribution prior to completion of all required post sterilization release activities.
Z-0742-2018 March 7, 2018 Queensbury, NY
Cook Inc.
Class II Terminated
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Z-0832-2018 March 7, 2018 Bloomington, IN
Cook Inc.
Class II Terminated
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Z-0830-2018 March 7, 2018 Bloomington, IN
Terumo Medical Corporation
Class II Terminated
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic d...
Reason: The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Z-0725-2018 March 7, 2018 Elkton, MD
Cook Inc.
Class II Terminated
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Z-0831-2018 March 7, 2018 Bloomington, IN
Arrow International Inc
Class II Terminated
Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0649-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0658-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0654-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0651-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0656-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0648-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0650-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 20...
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0652-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0655-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0647-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0653-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).
Z-0657-2018 February 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Reason: The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
Z-0690-2018 February 28, 2018 Reading, PA
Cook Inc.
Class II Terminated
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for trea...
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Z-0632-2018 February 21, 2018 Bloomington, IN
Arrow International Inc
Class II Terminated
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Reason: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR s...
Z-0601-2018 February 21, 2018 Reading, PA
Cook Inc.
Class II Terminated
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is ...
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Z-0633-2018 February 21, 2018 Bloomington, IN
Arrow International Inc
Class II Terminated
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Reason: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR s...
Z-0602-2018 February 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Reason: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Z-0486-2018 February 21, 2018 Reading, PA
Cook Inc.
Class II Terminated
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous...
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Z-0634-2018 February 21, 2018 Bloomington, IN