RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
The recalled children's craft buttons contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.
The wood lathe's cutting tool can break, posing an injury hazard due to projectiles that can strike the user and bystanders, and a laceration hazard to the user who could come into direct contact with the cutting tool.
The boiler's flue collector can crack if exposed to a high impact event in the burner chamber, which can allow the boiler to emit carbon monoxide, posing a risk of carbon monoxide poisoning.
The bath seats fail to meet the federal safety regulation for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.
The recalled loungers fail to meet the safety requirements of CPSC's Infant Sleep Products Rule, creating an unsafe sleeping environment for infants and posing a suffocation risk and fall and entrapment hazards to infants. The failures include not having a stand and not meeting the requirements for side height and fabric-sided openings. The product's sides are shorter than the minimum side height limit; the sleeping pad's thickness exceeds the maximum limit; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped.