FDA Device Intelligence
Home › Cardinal Health 200, LLC › CARDINAL HEALTH

CARDINAL HEALTH

Cardinal Health 200, LLC · Model SAN23CRVA3 · UDI-DI 10197106976517

OES Prescription
0
510(k) clearances
481
Adverse events (2 deaths)
92
Recalls
30
Facilities

Description

CARDIAC CATH PACK

Recalls

DateFirmReason
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-06-17Windstone Medical Packaging, Inc.Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. El
2026-05-28Medline Industries, LPKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th
2026-05-28Medline Industries, LPKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th
2026-05-21Medline Industries, LPThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu
2026-05-19AVID Medical, Inc.Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac
2026-04-30AVID Medical, Inc.Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol
2026-04-30AVID Medical, Inc.Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.