FDA Device Intelligence
HomeCardinal Health 200, LLC › CARDINAL HEALTH

CARDINAL HEALTH

Cardinal Health 200, LLC · Model SBA43DBT16 · UDI-DI 10197106935774

OVN Prescription
0
510(k) clearances
40
Adverse events
10
Recalls
34
Facilities

Description

DR BOYER ACCESSORY PACK

Recalls

DateFirmReason
2026-03-09LSL Healthcare Inc.Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
2025-12-12Medline Industries, LPMedline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

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.