Vascular Solutions LLC
Maple Grove, MN, US
VASCULAR SOLUTIONS LLC appears in FDA device records in Maple Grove, MN. FDA records list 115 510(k) clearances between and , 32 PMA records and one registered establishment. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 115FDA records hold 115 510(k) clearances for Vascular Solutions LLC between 2002 and 2024. The busiest year on record is 2007, with 14. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 7 |
| 2004 | 6 |
| 2005 | 13 |
| 2006 | 6 |
| 2007 | 14 |
| 2008 | 6 |
| 2009 | 9 |
| 2010 | 5 |
| 2011 | 7 |
| 2012 | 3 |
| 2014 | 5 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 10 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | LOX | Substantially Equivalent | |
| K230637 | Wattson temporary pacing guidewire (2250) | DQX | Substantially Equivalent | |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | DQY | Substantially Equivalent | |
| K221470 | Langston dual lumen catheter | DQO | Substantially Equivalent | |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | DQY | Substantially Equivalent | |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | DQX | Substantially Equivalent | |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | Substantially Equivalent | |
| K193119 | Twin-Pass Dual Access Catheter | DQY | Substantially Equivalent | |
| K200720 | D-Stat Radial Topical Hemostat | QSX | Substantially Equivalent | |
| K192454 | Wattson Temporary Pacing Guidewire | DQX | Substantially Equivalent | |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | DQY | Substantially Equivalent | |
| K182570 | Venture 0.014 Catheter | DQY | Substantially Equivalent | |
| K182232 | Octane Mechanical Thrombectomy System | QEZ | Substantially Equivalent | |
| K181647 | Bandit guidewire | DQX | Substantially Equivalent | |
| K180913 | VSI Micro-Introducer Kit | DYB | Substantially Equivalent | |
| K180088 | TrapLiner catheter | DQY | Substantially Equivalent | |
| K180128 | Warrior 14 guidewire | DQX | Substantially Equivalent | |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | KRD | Substantially Equivalent | |
| K173532 | Raider Guidewire | DQX | Substantially Equivalent | |
| K173266 | Octane aspiration system | QEZ | Substantially Equivalent | |
| K170544 | Langston dual lumen catheter | DQO | Substantially Equivalent | |
| K171946 | Gel-Bead | KRD | Substantially Equivalent | |
| K172090 | GuideLiner V3 Catheter | DQY | Substantially Equivalent | |
| K171335 | Venture 038 catheter | DQY | Substantially Equivalent | |
| K163307 | Expro Elite Snare, Sympro Elite Snare | MMX | Substantially Equivalent | |
| K161901 | TrapLiner catheter | DQY | Substantially Equivalent | |
| K162467 | Twin-Pass Torque | DQY | Substantially Equivalent | |
| K163444 | Spectre guidewire | DQX | Substantially Equivalent | |
| K161702 | Endura guidewire | DQX | Substantially Equivalent | |
| K162272 | Fluent inflation device | MAV | Substantially Equivalent | |
| K161336 | VSI StraitSet micro-introducer kit | DRE | Substantially Equivalent | |
| K152387 | Fluent Inflation Device | MAV | Unknown | |
| K151234 | R350 guidewire | DQX | Substantially Equivalent | |
| K142065 | TURNPIKE CATHETER | DQY | Substantially Equivalent | |
| K143038 | Gel-Block 10X embolization pledgets | KRD | Substantially Equivalent | |
| K133237 | GEL-BEAD EMBOLIZATION SPHERES | KRD | Substantially Equivalent | |
| K132789 | FLIP INTRODUCER ACCESS KIT | DYB | Substantially Equivalent | |
| K133501 | LEADLINER CS LEAD DELIVERY SYSTEM | DQY | Substantially Equivalent | |
| K120707 | SWITCH-IT CATHETER | DQY | Substantially Equivalent | |
| K113266 | GEL-BLOCK EMBOLIZATION PLEDGETS | KRD | Substantially Equivalent | |
| K112100 | M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER | DQY | Substantially Equivalent | |
| K113140 | VARI-LASE WIREFIBER LASER FIBER | GEX | Substantially Equivalent | |
| K112082 | GUIDELINER V2 CATHETER | DQY | Substantially Equivalent | |
| K112631 | VSI GUIDEWIRE | DQX | Substantially Equivalent | |
| K112571 | XL EXTRACTION CATHETER | QEZ | Substantially Equivalent | |
| K111334 | BENELLI ACCESS DEVICE | DQY | Substantially Equivalent | |
| K102212 | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER | QSX | Substantially Equivalent | |
| K101604 | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V | DYB | Substantially Equivalent | |
| K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH | QEZ | Substantially Equivalent | |
| K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2134812 | 3002827704 | VASCULAR SOLUTIONS LLC | 6464 Sycamore Court North, Maple Grove, MN 55369 US | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- LMFAgent, Absorbable Hemostatic, Collagen Based
- CAZAnesthesia Conduction Kit
- QEZAspiration Thrombectomy Catheter
- FCGBiopsy Needle
- OFCCatheter Introducer Kit
- BSOCatheter, Conduction, Anesthetic
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- DXCClamp, Vascular
- MGBDevice, Hemostasis, Vascular
- MMXDevice, Percutaneous Retrieval
- KRDDevice, Vascular, For Promoting Embolization
- DREDilator, Vessel, For Percutaneous Catheterization
- MHWDressing, Compression
- LDFElectrode, Pacemaker, Temporary
- QSXHemostatic Wound Dressing With Thrombin Or Other Biologics
- KNWInstrument, Biopsy
- DYBIntroducer, Catheter
- GCBNeedle, Catheter
- FMINeedle, Hypodermic, Single Lumen
- IQIOrthosis, Limb Brace
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- GEXPowered Laser Surgical Instrument
- MAVSyringe, Balloon Inflation
- FMFSyringe, Piston
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- FTYTape, Measuring, Rulers And Calipers
- ITXTransducer, Ultrasonic, Diagnostic
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0113-2021 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Terminated | |
| Z-0112-2021 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Terminated | |
| Z-0111-2021 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Terminated | |
| Z-0110-2021 | Langston Dual Lumen Catheter | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Terminated | |
| Z-1747-2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Terminated | |
| Z-2249-2018 | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures. | The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins. | Class II | Terminated | |
| Z-2224-2017 | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents | Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use. | Class I | Terminated | |
| Z-2180-2017 | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device. | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection. | Class II | Terminated | |
| Z-1250-2017 | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites. | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. | Class II | Terminated | |
| Z-0055-2017 | 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 and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen. | 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 distal portion of the rapid exchange lumen. | Class I | Terminated | |
| Z-0054-2017 | 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/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen. | 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 distal portion of the rapid exchange lumen. | Class I | Terminated | |
| Z-0053-2017 | 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 coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen. | 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 distal portion of the rapid exchange lumen. | Class I | Terminated | |
| Z-1275-2016 | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi. | Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism. | Class I | Terminated | |
| Z-1981-2014 | Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies. | The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury. | Class I | Terminated | |
| Z-0955-2013 | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures. | Risk that air may be introduced into the device which may lead to an air embolism. | Class I | Terminated | |
| Z-0868-2013 | 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 catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents | 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 during in-house testing. | Class II | Terminated | |
| Z-2400-2012 | Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. | Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination. | Class II | Terminated | |
| Z-1655-2012 | Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices. | Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention. | Terminated | ||
| Z-2946-2011 | Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. | Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury and/or procedural delay, resulting in a deteriorating hemodynamic condition of the patient which may require medical intervention. | Terminated | ||
| Z-2770-2011 | Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients. | Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal, posing a risk of product contamination. It is possible that a compromised sterile barrier | Terminated | ||
| Z-1521-2011 | Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369 The VARI-LASE WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity. | Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the endovenous laser fiber cage and guidewire tip of the WireFiber became separated. It is possible that separation could occur during patient procedure and has the p | Terminated | ||
| Z-2608-2010 | Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Usage: Indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, This type of pressure measurement is useful in determining transvalvular, intravascular and interventricular pressure gradients. | Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possib | Terminated | ||
| Z-0547-2010 | Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide. Manufactured by: Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369 USA. | It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009. | Terminated | ||
| Z-1712-2009 | Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents. | Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging | Terminated | ||
| Z-0144-06 | D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic bandage (D-Stat 2 Dry) consists of the following components: -One (1) scored lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride; -Two (2) Adhesive bandages. | A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question. | Terminated |
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