The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Other Medical Devices
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The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
NM/CT 850 Model Number: H3907AD
GE Healthcare
Rotor bearing screws were found loose on detector.
Reagents were shipped to customers after the Use by data indicated on its labeling.
Central Line Dressing Change Tray
Medline Industries
Potential of incomplete seals impacting the sterility of the kit.
Discovery NM 630 Model # H3101RH
GE Healthcare
Rotor bearing screws were found loose on detector.
EVOLVE STEM 8.5MM Model # 496S085
Wright Medical Technology
Lack of sterility assurance
Discovery NM670 Pro Model # H3100XB
GE Healthcare
Rotor bearing screws were found loose on detector.
NM/CT 870 DR Model # H3100AS
GE Healthcare
Rotor bearing screws were found loose on detector.
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Beckman Coulter
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
NM/CT 870 CZT Model # H3906CW
GE Healthcare
Rotor bearing screws were found loose on detector.
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
NM 830 Model # H3910AC
GE Healthcare
Rotor bearing screws were found loose on detector.
Discovery 670 DR Model # H3100BT
GE Healthcare
Rotor bearing screws were found loose on detector.
NM/CT 860, SPECT/CT
GE Healthcare
Rotor bearing screws were found loose on detector.
The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.