Class I - Dangerous
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Zimmer Biomet
Class I - Dangerous
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Class I - Dangerous
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Class I - Dangerous
Distribution of unapproved product labeling
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard.
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Sorin CRM SAS
Class I - Dangerous
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
ICU Medical de Mexico, S.A. de C.V.
Class I - Dangerous
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Mix-up between adult and pediatrics PD catheter.
H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module.
Class I - Dangerous
The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.