NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 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...
Reason: Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with ...
Z-1271-2016April 6, 2016Minneapolis, MN
Cook Inc.
Class IITerminated
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used...
Reason: Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-u...
Z-1237-2016March 30, 2016Bloomington, IN
Cook Inc.
Class IITerminated
Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Uretera...
Reason: Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-u...
Z-1238-2016March 30, 2016Bloomington, IN
Covidien LLC
Class IITerminated
Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STAND...
Reason: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Z-1218-2016March 30, 2016North Haven, CT
Cordis Corporation
Class IITerminated
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an int...
Reason: Incorrect cannula of the sheath introducer (smaller than intended).
Z-1174-2016March 23, 2016Miami Lakes, FL
Abbott Vascular
Class ITerminated
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product n...
Reason: Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the...
Z-0911-2016March 16, 2016Temecula, CA
Arrow International Inc
Class IITerminated
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port...
Reason: Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potent...
Z-1064-2016March 16, 2016Reading, PA
Cook Inc.
Class ITerminated
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coatin...
Reason: A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separ...
Z-0802-2016March 2, 2016Bloomington, IN
Cook Inc.
Class ITerminated
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are desi...
Reason: A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separ...
Z-0800-2016March 2, 2016Bloomington, IN
Cook Inc.
Class ITerminated
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis....
Reason: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occludi...
Z-0798-2016March 2, 2016Bloomington, IN
Cook Inc.
Class ITerminated
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coati...
Reason: A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separ...
Z-0801-2016March 2, 2016Bloomington, IN
Cook Inc.
Class IITerminated
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and intervention...
Reason: Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Z-0865-2016March 2, 2016Bloomington, IN
Cook Inc.
Class ITerminated
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are ...
Reason: A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separ...
Z-0799-2016March 2, 2016Bloomington, IN
EKOS Corporation
Class IITerminated
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (...
Reason: The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed ...
Z-0864-2016March 2, 2016Bothell, WA
C.R. Bard, Inc.
Class IIITerminated
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter...
Reason: Report by a customer of an open package seal.
Z-0812-2016February 24, 2016Covington, GA
Sorin Group USA, Inc.
Class IITerminated
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Car...
Reason: Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
Z-0813-2016February 24, 2016Arvada, CO
Spectranetics Corp.
Class IITerminated
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System...
Reason: The product is labeled with an expiration date that is past its shelf life.
Z-0758-2016February 17, 2016Colorado Springs, CO
Acist Medical Systems
Class IITerminated
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT20...
Reason: Reports related to ingress of air into the manifold.
Z-0744-2016February 10, 2016Eden Prairie, MN
Cook Medical Incorporated
Class IITerminated
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Reason: Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Fai...
Z-0689-2016February 3, 2016Bloomington, IN
Stryker Sustainability Solutions
Class ITerminated
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a m...
Reason: Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserti...
Z-0478-2016January 13, 2016Phoenix, AZ
Boston Scientific Corporation
Class IITerminated
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead De...
Reason: Potential for separation of the proximal handle from the shaft.
Z-0588-2016January 13, 2016Saint Paul, MN
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheteriza...
Reason: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Z-0554-2016January 6, 2016Hartland, WI
RenovoRx, Inc.
Class IITerminated
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow an...
Reason: Incorrect version of Instructions for Use were shipped to two US customers.
Z-0565-2016January 6, 2016Los Altos, CA
CareFusion 303, Inc.
Class IITerminated
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Reason: CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.