Cath lab procedure kits recalled due to ongoing safety concern
AVID Medical is recalling certain cath lab procedure kits because they include Medline manifolds that were part of a separate recall first announced in May.
These kits do not need to be returned to the manufacturer and they can still be used by interventional cardiologists to treat patients. However, the U.S. Food and Drug Administration (FDA) and AVID Medical are urging customers to place a warning label on all affected kits to ensure the affected manifolds are not used.
The AVID Medical kits included in this recall include:
- Cardiac Cath Pack – EAMC1000-05
- Heart Cath, Self Regional – SELF131-05
- SAMMC Angiography – SAMM066-15
Why were these manifolds recalled in the first place?
The manifolds at the heart of this issue were originally recalled due to the presence of particulate.
“Particulate within the manifold fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels,” according to an advisory shared by the FDA. “This carries a risk of serious injury, such as tissue or organ ischemia, or death.”
If using the included manifold is unavoidable because no other options are available and delaying care could do harm to the patient, clinicians should proceed with “extreme caution and vigilance.” For example, they should perform a full flush of the manifold with saline and carefully look it over for any signs of particulate.
More details about the warning labels
The warning labels customers place on these procedure kits should be applied in a “prominently visible location” that does not cover any information on the existing product label. If customers want any labels that have already been printed, they can request them from their AVID Medical sales representative.
Click here for additional information from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.