Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
Prodimed Plastimed Division
Class I - Dangerous
Lack of assurance of sterility
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Class I - Dangerous
This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Finished goods inventory was detected with damage to their seals in the form of breaches or folds. Based on our investigation the issue appears to be limited to a single lot of part number 902101226 pump tubing sets.
Class I - Dangerous
Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supraglottic airway to create a secure seal in the patient s airway as intended by the kit
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Prodimed Plastimed Division
Class I - Dangerous
Lack of assurance of sterility
Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
Centurion Medical Products
Class I - Dangerous
False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
Class I - Dangerous
Reports received of the device fracturing during insertion.
Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
Class I - Dangerous
Reports received of the device fracturing during insertion.
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
Class I - Dangerous
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Class I - Dangerous
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Extra corporeal circuit with bio-active surface.
Medtronic Perfusion Systems
Class I - Dangerous
Affected products failed a sterilization test.
Class I - Dangerous
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
Prodimed Plastimed Division
Class I - Dangerous
Lack of assurance of sterility
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
TeDan Surgical Innovations
Class I - Dangerous
Lack of pouch seal. Product is labelled as sterile.
Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
Philips North America
Class I - Dangerous
Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.