Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
🏥
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Class I - Dangerous
The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.
Class I - Dangerous
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Class I - Dangerous
The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N
Class I - Dangerous
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo
DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa
Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
Mar Cor Purification
Class I - Dangerous
There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Class I - Dangerous
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
Class I - Dangerous
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
The product may be mislabeled and could result in the incorrect implant being used.