Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0487-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0431-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0447-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0456-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0457-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0464-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0448-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0435-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0443-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0454-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0421-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0467-2020November 27, 2019Bloomington, IN
Cook Inc.
Class IITerminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper...
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0479-2020November 27, 2019Bloomington, IN
Canon Medical System, USA, INC.
Class IITerminated
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position pati...
Reason: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Z-0360-2020November 20, 2019Tustin, CA
Smiths Medical ASD Inc.
Class IITerminated
ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Reason: Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
Z-0352-2020November 20, 2019Minneapolis, MN
Becton Dickinson & Company
Class IITerminated
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injectio...
Reason: A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
Z-0285-2020November 13, 2019Franklin Lakes, NJ
Cordis Corporation
Class IITerminated
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Reason: Product was manufactured utilizing an expired inner body.
Z-0250-2020November 6, 2019Miami Lakes, FL
Arrow International Inc
Class IITerminated
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue P...
Reason: Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a cath...
Reason: Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Z-0123-2020October 23, 2019Galway, N/A
Centurion Medical Products Corporation
Class IITerminated
NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
Reason: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed ...
Z-0078-2020October 16, 2019Williamston, MI
Becton Dickinson & Company
Class IITerminated
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
Reason: After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if...
Reason: Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Z-0065-2020October 16, 2019Fremont, CA
Arrow International Inc
Class IITerminated
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment o...
Reason: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
Z-0053-2020October 16, 2019Reading, PA
Medtronic Vascular
Class ICompleted
SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.