Category: Medical Devices

Name of product:
Snowboard boots
Hazard:

The boots can release from the binding unexpectedly, posing a fall hazard to the user.

Remedy:
Repair
Recall date:
July 11, 2018
Units:
About 4,800
Consumer Contact:

Burton at 800-881-3138 from 8 a.m. to 6 p.m. ET Monday through Friday, email at info@burton.com or online at www.burton.com and click on “Step On Heel Cleat Update” for more information.

Recall Details

Description:

This recall involves Step On snowboard boots from the winter 2017-2019 seasons. The recalled boots were sold in a variety of colors. The model name is printed on the inside of the boot tongue.

 

Season Model Name Color
Winter 17-18 Sales Sample PHOTON STEP-ON BOOT BLACK
Winter 17-18 Sales Sample PHOTON STEP-ON BOOT BLUE PRINT
Winter 17-18 Sales Sample FELIX STEP-ON BOOT BLACK
Winter 17-18 Sales Sample FELIX STEP-ON BOOT STATIC
Winter 17-18 Sales Sample RULER STEP-ON BOOT BLACK
Winter 17-18 Sales Sample RULER STEP-ON BOOT GREY TIE DYE
Winter 17-18 Sales Sample RULER STEP-ON BOOT TAN
Winter 17-18 Sales Sample LIMELIGHT STEP-ON BOOT BLACK
Winter 17-18 Sales Sample LIMELIGHT STEP-ON BOOT BLACK/MULTI
Winter 17-18 Sales Sample LIMELIGHT STEP-ON BOOT TAN
Winter 17-18 Production PHOTON STEP ON BOOT BLACK
Winter 17-18 Production PHOTON STEP ON BOOT BLUE PRINT
Winter 17-18 Production FELIX STEP ON BOOT BLACK
Winter 17-18 Production FELIX STEP ON BOOT STATIC
Winter 17-18 Production RULER STEP ON BOOT BLACK
Winter 17-18 Production RULER STEP ON BOOT GREY TIE DYE
Winter 17-18 Production LIMELIGHT STEP ON BOOT BLACK
Winter 17-18 Production LIMELIGHT STEP ON BOOT BLACK/MULTI
Winter 18-19 Sales Sample PHOTON STEP ON BOOT CLOVER
Winter 18-19 Sales Sample PHOTON STEP ON BOOT BLACK
Winter 18-19 Sales Sample FELIX STEP ON BOOT BLACK
Winter 18-19 Sales Sample RULER STEP ON BOOT BLACK
Winter 18-19 Sales Sample RULER STEP ON BOOT BLACK/CAMO
Winter 18-19 Sales Sample LIMELIGHT STEP ON BOOT BLACK
Winter 18-19 Sales Sample LIMELIGHT STEP ON BOOT MIDNITE BLOOM
Winter 18-19 Sales Sample ION STEP ON BOOT BLACK
Winter 18-19 Sales Sample ZIPLINE STEP ON BOOT BLACK
Winter 18-19 Sales Sample PHOTON STEP ON – ASIAN FIT BOOT CLOVER
Winter 18-19 Sales Sample PHOTON STEP ON – ASIAN FIT BOOT BLACK
Remedy:

Consumers should immediately stop using the recalled snowboard boots and contact Burton to receive a free new heel cleat. Burton is contacting all known purchasers directly.

Incidents/Injuries:

Burton has received seven reports of the boots releasing from the binding unexpectedly. No injuries have been reported. (more…)

For Immediate Release

June 1, 2018

Contact

Consumers

 info@sun-med.com
 1-800-433-2797

Announcement

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuries to date.

End users who have STAT-Check or Medline resuscitator bags within the lot numbers listed below should stop using them and immediately contact SunMed Holdings, LLC for further instructions on the return of these products.

The list below provides the resuscitator bag series, features, and respective lot numbers of the recalled models:

STAT-Check MANUAL RESUSCITATOR I VENTILATOR, REF SC9200MBP-1;
Lot Numbers: 313406, 313447, 313164, 313165 & 313166

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116;
Lot Numbers:313298,313516,313588,313589, 313058,313060,313125,313173,313297,
313714, 313715 & 313774

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F;
Lot Number: 313238

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, FILTER, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC;
Lot Numbers: 313444 & 313239

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P;
Lot Number: 313545

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, PEEP VALVE, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC;
Lot Number: 313235

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG
RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5;
Lot Numbers: 313326, 313436 & 313049

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126;
Lot Numbers: 313546, 313717, 313176 & 313772

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1126C;
Lot Numbers: 313321, 313437, 313080 & 313193

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F;
Lot Numbers: 313471, 313627 & 313696

MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE
RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL;
Lot Numbers: 313363 & 313738

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP;
Lot Numbers: 313323, 313355, 313739, 313031, 313093, 313190 & 313272

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, FILTER, PEEP VALVE, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC;
Lot Number: 313315

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P;
Lot Numbers: 313502 & 313741

The recalled products were distributed nationwide and can be identified by the part number, description, and lot number on the case labels, as well as a label on the individual packaging bag. (more…)

For Immediate Release

September 27, 2017

Contact

Consumers

Jackie Jaskula
 j.jaskula@origen.com
 1-512-474-7278

Announcement

On August 2, 2017, OriGen Biomedical initiated a recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters.

Customers who have received product from either of these lots of VV28F Reinforced Dual Lumen ECMO Catheters should return any product that they currently have to OriGen Biomedical.

OriGen VV28F Reinforced Dual Lumen ECMO Catheters described below have been recalled:

Catalog number Lot number Manufacture date Expiration date
VV28F N18487 August 14, 2014 August 30, 2018
VV28F N18487-1 April 15, 2015 April 30, 2019

The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less (USA) or less than 29 days (rest of world).

OriGen Biomedical voluntarily recalled OriGen VV28F Reinforced Dual Lumen ECMO Catheters Lot N18487 and N18487-1 after becoming aware of a reported adverse event. OriGen Biomedical has notified the FDA of this action.OriGen Biomedical is aware of two (2) product failures and has received a complaint associated with each of the two (2) product failures.  A recurrence of this event could result in serious patient injury. (more…)

For Immediate Release

September 11, 2017

Contact

Consumers

 1-800-204-7616

Media

Pamela Reese
 1-818-576-3398
Fernando Vivanco
 1-763-505-3780

Announcement

Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall. “Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”

Customer Instructions
Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. Medtronic would like to remind customers that it is very important to carefully follow the Key Steps document included with the recall notification letter regarding the priming/fill-tubing process – especially if a person only has recalled infusion sets. (more…)

For Immediate Release

August 24, 2017

Contact

Consumers

 CustomerRelationsNA@Cook
Medical.com

 1-800-457-4500 or
1-812-339-2235

Media

Kacey Martin, Content Specialist,
PR and Social Media
 kacey.martin@cookmedical.com
 1-812-339-2235 ext. 5164

Announcement

On June 22, 2017, Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase. (more…)

For Immediate Release

May 3, 2017

Contact

Consumers

Isa Rizk
 949-481-0399

Announcement

On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.

The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.

ReFlow Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action. (more…)

For Immediate Release

May 3, 2017

Contact

Consumers

Isa Rizk
 949-481-0399

Announcement

On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.

The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.

ReFlow Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit. (more…)

For Immediate Release

April 6, 2017

Contact

Consumers

Candy Bowen
+1-904-332-8163

Media

Ryan Weispfenning
+1-763-505-4626

Announcement

DUBLIN – April 6, 2017 – Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed. (more…)

For Immediate Release

April 5, 2017

Contact

Consumers

Technical Support Department
 1-800-255-6774

Announcement

Medtronic (NYSE: MDT) is notifying customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. The reported incidence of this condition is approximately one (1) reset in every seven million hours of ventilation. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator.

A Newport HT70 ventilator is used to support a patient’s breathing. This prescription device is operated by trained healthcare professionals in a clinical setting and in the home for infant, pediatric and adult patients.

Since Aug. 2012, and of the more than 14,000 ventilators in use, Medtronic has received 12 reports of the reset without an accompanying alarm. Of these 12 reports, 11 patients required ventilator transfer and one (1) incident did not involve a patient. No patient injury or impairment has been reported. (more…)

For Immediate Release

January 13, 2017

Contact

Consumers

Physio-Control
rsrecalls@physio-control.com
1-866-231-1220

Media

Matt Fikse
matt.fikse@physio-control.com
425-867-4208

Announcement

(Redmond, WA) – January 13, 2017 – Physio-Control announced today that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.

The company is notifying LIFEPAK 1000 customers of an issue that may affect the readiness of the device. The company has received 34 reports where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. The company is aware of 8 adverse events related to this issue. (more…)