Critical Alert
AVID Medical Recalls Halyard HEART CATH
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-1975-2026Medical Device
AVID Medical Recalls Halyard HEART CATH
AVID Medical, Inc. · Class I — Most Serious
Product Description
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Reason for Recall
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
US distribution to FL, IL, MO, MS, NC, NE, TX.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database