Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be
Class I - Dangerous
Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limi
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.