FDA Classifies AVID Medical Convenience Kit Correction as Class I
FDA has classified the correction of AVID Medical convenience kits containing Medline Namic Star Off Handle Manifolds as Class I following reports of particulate within the fluid path, which may lead to vessel blockage, tissue ischemia, or death.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
AVID Medical corrected certain convenience kits after component manufacturer Medline identified particulate matter within the fluid path of Namic Angiographic Star Off Handle Manifolds during manufacturing. If particulate enters patient blood circulation during catheterization or angiography, it can lodge in blood vessels and may result in tissue or organ ischemia, embolism, or death. As of June 30, 2026, AVID Medical had reported no serious injuries or deaths associated with this issue.
MedTech Current analysis
Why it matters
The failure mode presents a severe patient-safety risk during vascular procedures, while the correction depends on kit-level traceability and clear clinical labeling because other sterile kit components may remain usable. Healthcare facilities need to isolate kits containing the recalled manifolds, and kit assemblers should assess how a subcomponent recall is identified, communicated, and controlled across downstream procedural trays.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisManufacturers and suppliersReview traceability and field-action procedures for recalled subcomponents incorporated into convenience kits or procedure packs.
- MedTech Current analysisHealthcare facilities and professionalsReconcile affected kit inventory by lot and make the manifold warning visible to catheterization and angiography teams before kits are opened.
- MedTech Current analysisGeneral MedTech readersFollow the FDA notice and the firm's instructions for the complete affected-lot list and correction process.
Official recall information
Official actions
According to the FDA communication:
- Identify, segregate, and quarantine all impacted convenience kits in facility inventory.
- Apply warning labels in a prominently visible location on affected kits so clinical users are alerted to the subcomponent recall notice before opening.
- Ensure warning labels do not obscure other critical product information or existing labeling.
- Contact the sales representative if pre-printed labeling templates or replacement labels are required.
- Remove and discard the affected manifold before a procedure while using remaining kit supplies as needed; if its use is unavoidable because failure to proceed would cause direct patient harm, perform a full saline flush of the manifold and attached tubing and inspect fluid pathways for particulate.
- Notify downstream customers and consignees who received affected convenience kits.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
AVID Medical is correcting certain convenience kits containing angiographic manifolds following an earlier recall initiated by component manufacturer Medline. FDA has classified the action as a Class I recall, its most serious classification category.
The correction involves Halyard convenience kits packaged with Medline Namic Angiographic Star Off Handle Manifolds. Medline identified particulate matter within the fluid path of the manifolds during manufacturing. If introduced into patient blood circulation during catheterization or angiography, particulate can lodge within blood vessels, potentially resulting in tissue or organ ischemia, embolism, or death.
This is a device correction rather than a complete physical removal of all convenience-kit packaging. Unaffected components within the kits remain usable once proper warning labels are affixed and the recalled manifolds are segregated. As of June 30, 2026, AVID Medical had reported no serious injuries or deaths associated with this issue.
Who and what are affected
The correction affects 5,168 convenience kits distributed in the United States, including North Carolina and Texas. Affected products include cardiac catheterization and angiography procedural packs manufactured by AVID Medical, an Owens & Minor company.
| Description (Tray Name) | NAV Number | Model/Item Number | UDI-DI |
|---|---|---|---|
| Cardiac Cath Pack | 512628 | EAMC1000-05 | 10809160377314 |
| Heart Cath, Self Regional | 5313767 | SELF131-05 | 10809160408650 |
| SAMMC Angiography | 5308991 | SAMM066-15 | 10809160388495 |
Facilities should check specific lot numbers against the complete listing in the primary FDA notice. Only kits containing the recalled Medline Namic manifolds are subject to these correction requirements.
What affected organizations should do
Affected healthcare facilities
According to the FDA communication:
- Identify, segregate, and quarantine all impacted convenience kits in facility inventory.
- Apply warning labels in a prominently visible location on affected kits to ensure clinical users are alerted to the subcomponent recall notice before opening.
- Ensure the placement of the warning label does not obscure other critical product information or existing labeling.
- Contact the sales representative if pre-printed labeling templates or replacement labels are required.
- Continue using other unaffected sterile components within the convenience kit once appropriate labeling is in place.
Clinical users
According to the FDA communication:
- Do not use the affected Medline Namic manifolds under standard procedural conditions.
- Remove and discard the manifold before the procedure while using remaining kit supplies as needed.
- If manifold use is unavoidable because failure to proceed would cause direct patient harm, perform a full saline flush of the manifold and attached tubing.
- Inspect fluid pathways carefully and do not use the device if any particulate is visible.
Distributors
According to the FDA communication:
- Notify all downstream customers and consignees who received affected convenience kits.
- Provide consignees with the firm’s recall notification letter and maintain documentation of notification effectiveness.
MedTech Current analysis
Manufacturers and kit assemblers can review whether their component traceability, change-control, and field-action procedures identify every downstream kit configuration that contains a recalled subcomponent. Healthcare organizations can pair lot-level inventory reconciliation with a clear warning process for procedural teams, especially where a corrected kit remains in circulation with unaffected components. General readers should use the FDA notice and the firm’s instructions to confirm the affected lots and follow the specified correction process.