Category: Medical Devices

For Immediate Release

November 23, 2018

Contact

Consumers

Beckman Coulter Life Sciences
  customerrelations@beckman.com
 800-369-0333

Media

Chris Suttile
  csuttile@beckman.com
 317-672-8028

Announcement

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

In a safety notification letter distributed globally on January 9, 2018, Beckman Coulter Life Sciences notified FC 500 and EPICS customers of a potential intermittent or permanent failure of a purchased component on the circuit amplifier boards. This issue has the potential to impact all assays run on the cytometers for any application, including laboratory-developed tests. The potential for circuit amplifier board failure is latent, intermittent, or permanent, and may affect patient results as follows:

  • The failure could present itself as an intermittent or sudden signal loss, resulting in absence of data.
  • Alternatively, the failure could also present itself as a drift in signal including a sudden upward or downward shift in signal, an upward or downward drift in signal over time, a fluctuating signal, suboptimal compensation, erroneous results on affected parameters, and/or increased coefficients of variation (CV) of Flow-Check beads.

There are no known patient injuries reported to-date. (more…)

For Immediate Release

November 12, 2018

Contact

Consumers

Oscor’s Customer Relations Group
  TB@oscor.com
 727-937-2511

Announcement

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor Inc. is voluntarily taking this action.

INTENDED USE:

The Temporary Bipolar Pacing Lead, Model TB is used transvenously for temporary pacing and sensing of the heart in conjunction with a compatible external pulse generator.

DEVICE DESCRIPTION:

The temporary pacing lead is a bipolar lead with depth markings. The proximal end of the lead includes two 2mm (unshrouded) connectors which fit directly to most pulse generators or extension cable. The French size is printed on the lead hub.

REASON FOR THE VOLUNTARY PRODUCT REMOVAL:

During the use of some TB – Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system. No deaths were reported; however the risk for serious injury and/or death is a concern if the connectors separates during use. (more…)

For Immediate Release

September 27, 2018

Contact

Consumers

Oscor’s Customer Relations Group
  TB@oscor.com
 (727) 937-2511

Announcement

During the use of some TB – Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.  The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins.  In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system. No deaths were reported; however the risk for possible injury is a concern if the connectors separates during use. (more…)

For Immediate Release

September 20, 2018

Contact

Consumers

Helena Swan
  Helena.swan@getinge.com
 + 1 (973) 709-7967

Announcement

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

It is important to note, there have been no adverse events or deaths attributed to this issue. (more…)

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…)