ANCILLARY PACK-LF. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile Procedural Trays, labeled as the following: IM NAIL
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Olympus Corporation of the Americas
Class I - Dangerous
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
W L Gore & Associates
Class I - Dangerous
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Medtronic Perfusion Systems
Class I - Dangerous
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Carbon Medical Technologies
Class I - Dangerous
The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Medtronic Perfusion Systems
Class I - Dangerous
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
Medtronic Perfusion Systems
Class I - Dangerous
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Class I - Dangerous
Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.