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قائمة الأجهزة المسحوبة
إشعار السلامة الميدانية
قائمة الأجهزة المسحوبة
اشعارات السلامة الميدانية
قائمة الإجراءات التصحيحية للسلامة الميدانية
قائمة الأجهزة المسحوبة
LAL Chemicals & Cosmetics:
CleanLine Gel Ultrasound
Medtronic ltd:
Automated Surgical Stapling - Medtronic- missing components which may result in incomplete staple formation
6 French Sherpa NX Active Guide Catheters - Medtronic- risk of the outer material separating from the device resulting in detached fragments
Implantable infusion pump - Medtronic- presence of a foreign particle inside the pump motor assembly that interfere with motor gear rotation.
Endologix:
Nellix Endovascular- Endologix- failure of the treatment after two years of transplantation.
Terumo:
Terumo Needle and Terumo Needle Neolus- Terumo- presence of holes on the packaging which may affect the sterility of the product.
Geistlich:
Bio- Oss pen-Gestlish-appearance of a green visible particle on the outer barrel of the pen.
BrainLab:
Spine & trauma 3D Navigation-BrainLab- potential for incorrect information to display during
Ethicon Endo-Surgery, LLC:
Intraluminal staplers-Ethicon Endo-Surgery, LLC-occurrence of uncut washers and malformed staples with their
intraluminal circular staplers, which can compromise staple line integrity
Integra LifeSciences:
CSF Drainage System and Monitoring System-lntegra LifeSciences-possible breakage of the LimiTorr Transducer and
Monitorr Panel Mount Stopcock, device failure leads to infection, fever, headache, over drainage leading to subdural hematoma
Schiller:
Defibrillator Electrodes-Schiller-potential risk of no signals or energy will be transmitted, this results in failure to treat a patient in a life-threating condition
Becton Dickinson:
Alaris infusion pump-Becton Dickinson- bezel assemblies manufactured from plastic FR-110 plastic may separate or become damaged.
BD BBL™ Gram Crystal Violet 250mL- Becton Dickinson- increased levels of artifacts could result in a false-positive Gram stain.
BD BBL™ Gram Stain Kit- Becton Dickinson- increased levels of
artifacts could result in a false-positive Gram stain.
BD PCEA Patient Controlled Epidural Analgesia Administration Sets- Becton Dickinson- potential leak leads to inadequate pain control for the patient.
Venflon Pro Safety (VPS) Needle Protected IV Cannula - Becton Dickinson - potential leakage from the injection port
Bard Access System inc:
Equistream Long-term hemodialysis Catheter-Bard Access System inc- device may be at risk of containing a tunneler
with a plastic barb tip that is susceptible to breaking
Edward Lifescience:
Miller Balloon Catheter
VHK and VKMO Adult-Small Adult
EZ Glide Aortic Cannula
GE Healthcare:
Infant Warmers
Qiagen Sciences:
Filter tips
Smiths Medical:
Gripper Non-Coring Safety Needle
Intersurgical Lmited:
22F Economy Anethetic Face Masks
Bard:
Bard Max Core Biopsy Instrument
Bard GmbH:
Venous Stent System - BARD GmBh - the proximal end of the stent may not immediately expand upon deployment
Zimmer, INC:
Foot and Ankle Instruments
Teleflex Medical:
Intraosseous Vascular Access Needle Sets
Maquet Cardiopulmonary GmbH:
Quadrox ID Pediatric with Biloine Coating
Depuy International Limited:
1.0 mm Cloverleaf Footplates and AB & BC Distractor Bodies
Mavidon Medical:
Skin Preparation Electrode gel
Synthes GmbH:
USS II Polyaxial 3D Heads
Abbott Vascular:
Coronary Dilatation Catheter
Tytek Medical:
PneumoDart-Pneumothorax Needle
Bonn Medical Industries:
Shield Hand Sanitizing Gel
United Chemical Technology:
MaxClean Sanitizing Gel
Sastech Detergent Manufacturing co. W.L.L:
Sastech Hygiene
Rayt Albayan for Disinfected and Cosmetic:
First Hand Sanitizing Gel
Cleaning Force Chemical Factory:
Prodenty Hand Sanitizing Gel
AAP IMPLANTATE AG:
Soft Tissue Retractor, radiolucent
Smith & Nephew:
Footprint Ultra PK Suture Anchor
R3 Actebular Shells
Natus Medical Incorporated:
Olympic Brainz Monitor
Lotus:
Examination Gloves
My Perfume(MPF):
New NB Naturally Bold Hand Sanitizer Gel
Sailor Viking Cleaning and Cosmetic manufacturing Co:
Sailor Viking hand sanitizing gel
GETINGE:
HEMASHIELD GOLD/HEMASHIELD PLATINUM
Kingdom Detergents Factory:
Super Hand Sanitizing Gel
Chemistry Technical (Chem Tech) Detergent Company:
Chem Tech Hand Sanitizer
Baxter Healthcare:
PD 3L EMPTY Bag System & CAPD Pediatric set - Baxter Healthcare - problem with the sterilization process
Genicon, Inc:
A Li-Gator Single Use Laparoscopic Clip Applier - Genicon, Inc - Device malfunction causing the applier to jam, and clip loading failures
Multiple Manufacturers:
Hemodyalysis Venous Catheter Components
Implanted Hearing Devices
Hemospray Endoscopic Hemostat
Medical Devices Containing Mercury
Transvaginal Mesh
Pure gel_Delet_Hand Sanitizers
Hand Sanitizing Gels 1
Hand Sanitizing Gels 2
Vital Oxide Disinfectant- Vin Technology Systems (Vinner)-product being re-filled and re-packaged in a facility that is not licensed
CITOTEST transport Medium-
Citotest Labware Manufacturing Co - leakage in transportation tube
Chloraprep 3ml applicator - Becton Dickinson - breach in the package integrity.
SEPTIRAZ isopropyl alcohol - Al Razi Pharmaceutical Company- amount of sterile alcohol (Isopropanol) is less than 70%
Valera hand sanitizer - UNI care - amount of sterile alcohol (Ethanol) is less than 60%
Medical Latex Examination Gloves - Unknown manufacturer - potential risks associated with powdered gloves.
CleanLine Gel- LAL Chemicals & Cosmotics- high percentage of cytotoxicity which is not suitable for medical use
Pink Drop hand sanitizer - SAFIRES KOZMETIK-Presence of Methanol.
Hemospray Endoscopic Hemostat - Cook Medical - cracking or breaking in the handle and/or activation knob.
S Isopropyl Alcohol - S beauty group - presence of methanol
StageOne™ and StageOne™ Select Bone Cement Spacer Molds - Zimmer - insufficient cleaning process.
Sensor Nitinol Guidewire with Hydrophilic Tip -
BOSTON SCIENTIFIC -
difficulty or inability to track over the guidewire
Advia Centaur XPT HBsII Kits- Siemens - inability to calibrate the ADVIA Centaur HBsAg Confirmatory.
BARD SafeStep Huber Needle Sets -
Becton Dickinson -
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device
Imager II Angiographic Catheters - 5F curved tip shapes - BOSTON SCIENTIFIC - potential for the catheter tip to become detached during a procedure.
Glide Aortic Cannula - Edwards lifesciences LLC - separation of EZ Glide cannula from its connector leading to loss of blood.
CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M - Intersurgical Ltd - Masks without vents that would prevent the patient from breathing normally.
Recall of Previosly NIOSH and FDA Approved KN95 Masks.
Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery - Teleflex Medical - laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture leading to adverse health consequences.
Neonatal Resuscitation System - Intersurgical LTD - incorrect or missing connection interfaces.
better safe than sorry hand sanitizer - Bozhou Xunhetang biotechnology - Ethyl Alcohol percentage is higher than the accepted range and this may impact the effectiveness of the hand sanitizer to kill bacteria and microbes
.
Olympus TBNA Needle - Olympus - Sterility of the product is compromised due to a defective seal.
Alinity i HIV Ag/Ab Combo Calibrator - Abbott GmbH - manufacturing issue where impacted vials can cause invalid calibrations due to low RLU
.
BARD® MARQUEE® Disposable Core Biopsy Instruments and Kits - BARD GmBh - potential fault in the Penetration Depth Switch.
KN 95 Reapirators - Jiangxi Benguo Technology Co.,Ltd. - quality assurance certificate of product is no longer recognized and compliance to the international standards cannot be guaranteed.
Valiant Navion™ Thoracic Stent Graft System - Medtronic - serious adverse events e including stent fractures, endoleak and stent ring enlargement.
Implantable Cardioverter Defibrillator - Biotronik SE & Co.KG - likelihood of premature battery depletion.
Infusion Sets for Alaris™ Pump - Infusion Sets for Alaris™ Pump - falsified sterilization process by 3rd party sterilization services provider.
PICO70 Arterial Blood Sampler - Radiometer - issue relates to the sterile barrier system for the product.
AMS 700 with MS Pump - Boston Scientific - problem encountered during the initial activation of the device.
Covidien Dar airway products - Medtronic - potential deviations from validated parameters for ethylene oxide sterilization.
Disposable cuffs for tourniquet application - Ulrich Medical - the sterility of the affected products is not guaranteed.
Precise PRO Rx US Carotid System by Cordis - Cordis Corporation - risk of separation of the atraumatic distal tip of the sheathed delivery system in patients.
List of disapproved permanent inks
HeartWare™Ventricular Assist Device (HVAD™)System - Medtronic - delay / failure to restart could lead to serious patient harm or death.
Prismaflex TPE2000 set - Baxter - defect in sterilization process.
Hurricane™ RX Biliary Balloon Dilatation Catheter - Boston Scientific -
complaints reported for pinholes in the balloon.
contact
Lenses Solu
t
ion -
Bausch and Lomb INC - problem with the sterilization process.
DuoDERM Extra Thin and DuoDERM CGF adhesive -
ConvaTec Australia Pty Ltd
-
the adhesive wound dressings is not sealed together
completely,
wound dressings.
LeadCare Test Kits - Meridian Bioscience / Magellan Diagnostics -
risk of falsely low result
s.
Polyurethane Enteral Feeding Tube -
CAIR LGL -
a non
-
uniform yellow colour at different part on the tube.
Genle Guard powdered gloves - Syscon - gloves containing powder.
Falcon Pack Vinyl powdered gloves - Falcon pack -
gloves containing powder.
HotPack vinyl / latex powdered gloves - HotPack -
gloves containing powder.
Mini Med 640G Insulin Pump - Medtronic - damaged clear retainer ring.
Oxygen (O2)
Sensors - CooperSurgical - sensors are not accurate and give different readings without aralm.
COVID-19 Rapid Test Recall - imported and distributed without NHRA approval.
NIM
Trivantage EMG Endotracheal Tube - Medtronic - problems associated with the use of
Endotracheal Tube.
VACUTAINER BLOOD COLLECTION TUBE - Becton Dickinson
-
potential to underfill or exhibit draw volumes below labelled
product
claims.
Stomach Tube -
Suzhou New Area Mingji Macromolecule - existence of counterfeited stomach tube in the market.
Pulse Oximeter - quality and efficacy are not guaranteed, Not approved by NHRA.
BD OneFlow™ - BD - the material used to manufacture the affected products has uncharacteristic profile caused by CD8 contamination.
CarbonAid Co2 Diffuser -
Cardia Innovation AB - Counterfeited device in the market.
Emergency Chest Re
-
opening Pack -
Mölnlycke Health Care AB - malfunction of Sternal retractor devices.
EEA™ Autosuture™ Circular Stapler - Medtronic -
potential for the staple guide to not be securely attached to the
instrument.
BD Plastipak™ 50mL syringe – BD - observation of air in a damaged syringe while being used in a pump
Cooper Surgical HUMIDIFIER BOTTLES - Cooper Surgicals - potential breach to the sterile barrier due to packaging orientation of the filter box
.
ChemoLock Port – ICU medical - A potential for unintended disconnection, inability to connect to or fully engage with injectors
GELITA TUFT-IT/SPON® RAPID³/SPON® STANDAR - GELITA MEDICAL GmbH - The endotoxin concentration of the product in some samples has been measured above the limit.
CorVocet™ Biopsy System - Merit Medical Systems Inc. - product defect resulting from incorrect assembly.
MicroClave™ Clear Connector w/Red Ring - ICU Medical, Inc. - visible gap between the connector's top and bottom housing.
VITROS Immunodiagnostic Products HIV Combo - ORTHO DIAGNOSTIC CLINICS - potential for False Repeat Reactive Results and False Negative Results
.
Remel Rapid™ NF System – ThermoFisher - gave a positive reaction where it should have given a negative reaction within the NO3 well of the panel.
BD Veritor™ Plus Analyzer – BD - fire resultant from power issues could cause the user 2nd or 3rd degree burns
.
In-Ka® ureteral balloon dilatation catheter kit - Coloplast A/S - expiration date labelled is not correct.
NEO-FIT NEONATAL ENDOTRACHEAL TUBE GRIP SET - COOPER SURGICAL - metal clips used to grip the endotracheal tube may fracture and detach from the strap and then be ingested by the patient.
MicroClave
IV Connectors and Sets & Intravascular Admin Sets – ICU medical -
visible gap between the MicroClave Clear connector’s top and bottom housings.
Hy-Care® Multipurpose Contact Lens Care Solution – CooperVision - product may not offer appropriate levels of disinfection
.
BE & HLS set – GETINGE – Potentially compromised sterile barrier.
Original Perfusor® Line - B. Braun Melsungen AG - risk for holes and leakages in the device.
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جميع الحقوق محفوظة ©، الهيئة الوطنية لتنظيم المهن والخدمات الصية، مملكة البحرين. 2025.
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