Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mappi...
Reason: Mislabeled for size
Z-1708-2016June 1, 2016Tempe, AZ
Hummingbird Med
Class ITerminated
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
Reason: Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between the "Hummi" Y connector and the yellow cannula hub may not be suf...
Z-1636-2016June 1, 2016Lake Forest, CA
Becton Dickinson & Company
Class IITerminated
1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter...
Reason: The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
Z-1690-2016May 25, 2016Franklin Lakes, NJ
Medtronic Navigation, Inc.
Class IITerminated
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (...
Reason: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Z-1672-2016May 25, 2016Louisville, CO
Stryker Sustainability Solutions
Class IITerminated
Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
Reason: Device packaging may not be sealed.
Z-1626-2016May 18, 2016Tempe, AZ
Biosense Webster, Inc.
Class IITerminated
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple...
Reason: Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to p...
Z-1590-2016May 11, 2016Irwindale, CA
Biosense Webster, Inc.
Class IITerminated
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for mult...
Reason: Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to p...
Z-1591-2016May 11, 2016Irwindale, CA
Boston Scientific Corporation
Class IITerminated
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for pal...
Reason: Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Z-1567-2016May 4, 2016Marlborough, MA
Hansen Medical Inc
Class IITerminated
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of ...
Reason: Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Reason: Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation ...
Z-1552-2016May 4, 2016Minneapolis, MN
Coloplast Manufacturing US, LLC
Class IITerminated
Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 Fren...
Reason: Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters because a small portion of the lot was identified to have missing eyelets....
Z-1525-2016April 27, 2016Minneapolis, MN
Boston Scientific Corporation
Class ITerminated
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the p...
Reason: Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use...
Z-1342-2016April 27, 2016Maple Grove, MN
Customed, Inc
Class IITerminated
Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1423-2016April 20, 2016Fajardo, PR
Customed, Inc
Class IITerminated
Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1459-2016April 20, 2016Fajardo, PR
Customed, Inc
Class IITerminated
Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1412-2016April 20, 2016Fajardo, PR
Us Endovascular
Class IITerminated
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Reason: Product may kink during use rendering the product unusable.
Z-1362-2016April 20, 2016Saint Louis, MO
C.R. Bard, Inc.
Class IITerminated
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction an...
Reason: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Z-1357-2016April 20, 2016Covington, GA
C.R. Bard, Inc.
Class IITerminated
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical...
Reason: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Z-1358-2016April 20, 2016Covington, GA
Customed, Inc
Class IITerminated
Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1458-2016April 20, 2016Fajardo, PR
Customed, Inc
Class IITerminated
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1413-2016April 20, 2016Fajardo, PR
Merit Medical Systems, Inc.
Class IITerminated
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the r...
Reason: Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of t...
Z-1375-2016April 20, 2016South Jordan, UT
C.R. Bard, Inc.
Class IITerminated
BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, void...
Reason: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Z-1359-2016April 20, 2016Covington, GA
AngioDynamics Inc.
Class IITerminated
NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291...
Reason: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unabl...
Z-1344-2016April 13, 2016Glens Falls, NY
AngioDynamics Inc.
Class IITerminated
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enla...
Reason: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unabl...
Z-1345-2016April 13, 2016Glens Falls, NY
AngioDynamics Inc.
Class IITerminated
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarg...
Reason: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unabl...