Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is plac...
Z-0322-2017November 9, 2016Louisville, CO
Stryker Neurovascular
Class IITerminated
Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional device...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0344-2017November 9, 2016Fremont, CA
Stryker Neurovascular
Class IITerminated
Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional ...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0346-2017November 9, 2016Fremont, CA
Stryker Neurovascular
Class IITerminated
Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional de...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0343-2017November 9, 2016Fremont, CA
Stryker Neurovascular
Class IITerminated
Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventiona...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0345-2017November 9, 2016Fremont, CA
Stryker Neurovascular
Class IITerminated
Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devi...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0337-2017November 9, 2016Fremont, CA
Stryker Neurovascular
Class IITerminated
Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional ...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0333-2017November 9, 2016Fremont, CA
TZ Medical, Inc.
Class IITerminated
Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and followin...
Reason: Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
Z-0298-2017November 2, 2016Portland, OR
Sequent Medical Inc
Class IITerminated
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of...
Reason: Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.
Z-0114-2017November 2, 2016Aliso Viejo, CA
AccessClosure, Inc., A Cardinal Health Company
Class IITerminated
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path...
Reason: AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the abse...
Z-0297-2017November 2, 2016Santa Clara, CA
US Endoscopy Group Inc
Class IITerminated
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through fl...
Reason: US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assem...
Z-0289-2017October 26, 2016Mentor, OH
Vascular Solutions, Inc.
Class ITerminated
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary an...
Reason: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the d...
Z-0055-2017October 26, 2016Maple Grove, MN
Vascular Solutions, Inc.
Class ITerminated
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the ...
Reason: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the d...
Z-0053-2017October 26, 2016Maple Grove, MN
Vascular Solutions, Inc.
Class ITerminated
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/o...
Reason: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the d...
Z-0054-2017October 26, 2016Maple Grove, MN
Biocompatibles U.K., Ltd.
Class IITerminated
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can ha...
Reason: One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does ...
Z-0078-2017October 19, 2016Farnham, N/A
Integra LifeSciences Corp.
Class IITerminated
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary pack...
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Z-2907-2016October 12, 2016Plainsboro, NJ
Integra LifeSciences Corp.
Class IITerminated
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches ar...
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Z-2909-2016October 12, 2016Plainsboro, NJ
Integra LifeSciences Corp.
Class IITerminated
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Ca...
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Z-2905-2016October 12, 2016Plainsboro, NJ
Arrow International Inc
Class IITerminated
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Reason: Arrow is recalling due to incorrect labeling of products.
Z-2911-2016October 12, 2016Reading, PA
Argon Medical Devices, Inc
Class IITerminated
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Reason: The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dil...
Z-0051-2017October 12, 2016Athens, TX
Integra LifeSciences Corp.
Class IITerminated
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary pa...
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Z-2910-2016October 12, 2016Plainsboro, NJ
Zyno Medical LLC
Class IITerminated
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to adm...
Reason: Administration Set potential filter leaking
Z-2896-2016October 5, 2016Natick, MA
Zyno Medical LLC
Class IITerminated
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyn...
Reason: Administration Set potential filter leaking
Z-2893-2016October 5, 2016Natick, MA
Zyno Medical LLC
Class IITerminated
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zy...
Reason: Administration Set potential filter leaking
Z-2895-2016October 5, 2016Natick, MA
Zyno Medical LLC
Class IITerminated
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to ad...
Reason: Administration Set potential filter leaking