GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which conn...
Reason: Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
Z-0940-2013March 20, 2013Indianapolis, IN
Bard Access Systems
Class IITerminated
Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage:...
Reason: Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutane...
Z-0909-2013March 13, 2013Salt Lake City, UT
Bard Access Systems
Class IITerminated
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are ...
Reason: Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutane...
Z-0910-2013March 13, 2013Salt Lake City, UT
Medrad Inc
Class IITerminated
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to ...
Reason: The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accesso...
Z-0870-2013February 27, 2013Warrendale, PA
Vascular Solutions, Inc.
Class IITerminated
Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross cathe...
Reason: Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed...
Z-0868-2013February 27, 2013Maple Grove, MN
Merit Medical Systems, Inc.
Class IITerminated
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Reason: A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Z-0866-2013February 27, 2013South Jordan, UT
Carefusion 303 Inc
Class IITerminated
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
Reason: CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observe...
Z-0832-2013February 27, 2013San Diego, CA
Aesculap, Inc.
Class IITerminated
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to s...
Reason: The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust ...
Z-0805-2013February 20, 2013Center Valley, PA
Concentric Medical Inc
Class IITerminated
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-...
Reason: Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Z-0655-2013January 16, 2013Mountain View, CA
St Jude Medical Inc
Class IIITerminated
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiov...
Reason: St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve sty...
Z-0617-2013January 9, 2013Saint Paul, MN
Greatbatch Medical
Class IITerminated
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou...
Reason: Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may...
Z-0611-2013January 2, 2013Minneapolis, MN
Medtronic Neuromodulation
Class ITerminated
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a Synch...
Reason: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pu...
Z-0496-2013December 19, 2012Minneapolis, MN
Medtronic Neuromodulation
Class ITerminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and de...
Reason: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pu...
Z-0497-2013December 19, 2012Minneapolis, MN
Nipro Medical Corporation
Class IITerminated
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional de...
Reason: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing a...
Z-0134-2013October 31, 2012Miami, FL
Nipro Medical Corporation
Class IITerminated
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional d...
Reason: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing a...
Z-0137-2013October 31, 2012Miami, FL
Nipro Medical Corporation
Class IITerminated
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional...
Reason: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing a...
Z-0136-2013October 31, 2012Miami, FL
Greatbatch Medical
Class IITerminated
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou...
Reason: We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigatin...
Z-0132-2013October 31, 2012Minneapolis, MN
Nipro Medical Corporation
Class IITerminated
AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional d...
Reason: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing a...
Z-0138-2013October 31, 2012Miami, FL
Nipro Medical Corporation
Class IITerminated
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devi...
Reason: Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing a...
Z-0135-2013October 31, 2012Miami, FL
US Endoscopy Group Inc
Class IITerminated
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestin...
Reason: When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become...
Z-0006-2013October 10, 2012Mentor, OH
C.R. Bard, Inc., Urological Division
Class IITerminated
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used ...
Reason: The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
Z-0010-2013October 10, 2012Covington, GA
Cure Medical LLC
Class IITerminated
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialy...
Reason: The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud¿-tip catheters while the actual cont...
Reason: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Z-2446-2012October 3, 2012Rancho Santa Margarita, CA
Reason: On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. P...
Z-2442-2012October 3, 2012Miami Lakes, FL
Linvatec Corp. dba ConMed Linvatec
Class IITerminated
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump...
Reason: ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal...