Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 95 of 138
Arrow International Inc
Class II Terminated
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Reason: Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The ...
Z-1705-2017 April 12, 2017 Reading, PA
Medical Components, Inc dba MedComp
Class II Terminated
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascula...
Reason: The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F va...
Z-1536-2017 March 29, 2017 Harleysville, PA
Purewick Corporation
Class II Terminated
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw ...
Reason: PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This product contains dry natural rubber" and/or erroneously included the p...
Z-1485-2017 March 29, 2017 El Cajon, CA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1445-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1446-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1443-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1450-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1453-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1449-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1451-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1447-2017 March 22, 2017 Burlington, MA
CareFusion 303, Inc.
Class II Terminated
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or cathet...
Reason: CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
Z-1482-2017 March 22, 2017 San Diego, CA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1452-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1444-2017 March 22, 2017 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1448-2017 March 22, 2017 Burlington, MA
C2 Therapeutics, Inc.
Class II Terminated
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided ...
Reason: The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controll...
Z-1477-2017 March 22, 2017 Redwood City, CA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Z-1442-2017 March 22, 2017 Burlington, MA
Cook Inc.
Class II Terminated
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapere...
Reason: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which c...
Z-1391-2017 March 8, 2017 Bloomington, IN
Windstone Medical Packaging, Inc.
Class II Terminated
Catheter Pack, part number AMS4399(A
Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterilit...
Z-1280-2017 March 8, 2017 Billings, MT
Cook Inc.
Class II Terminated
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end c...
Reason: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which c...
Z-1392-2017 March 8, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheter...
Reason: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which c...
Z-1388-2017 March 8, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or...
Reason: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which c...
Z-1387-2017 March 8, 2017 Bloomington, IN
Arrow International Inc
Class II Terminated
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of...
Reason: There have been complaints for peel away sheaths flaring
Z-1228-2017 March 1, 2017 Reading, PA
Cardiovascular Systems Inc
Class II Terminated
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patie...
Reason: CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Z-1230-2017 March 1, 2017 Saint Paul, MN
Atrium Medical Corporation
Class II Terminated
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Reason: Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
Z-1221-2017 February 22, 2017 Hudson, NH