Class I - Dangerous
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Pro-Med Instruments Gmbh
Class I - Dangerous
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Pro-Med Instruments Gmbh
Class I - Dangerous
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
Class I - Dangerous
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
Class I - Dangerous
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Arrow International
Class I - Dangerous
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Class I - Dangerous
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Class I - Dangerous
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Class I - Dangerous
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Class I - Dangerous
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
SPS Sterilization
Class I - Dangerous
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.