Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
The crystals on the hairclip contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap and suffer serious injuries or death when the elevator is called to another floor.
Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap between the doors and suffer serious injuries or death when the elevator is called to another floor.
The space between the second rung of the bed's ladder and the lower bunk frame is wider than 3.5 inches, posing an entrapment hazard to children, when the mattress is removed.
Rockgeist Bikepack U.S.A., of Asheville, North Carolina
🏠 Consumer Products Class II - Moderate
The recalled bracket arms, attached to bicycle handlebars, can crack or break during use, causing the harness and gear to fall while the bicycle is in motion, posing a crash and injury hazards.