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

CARDINAL HEALTH

Cardinal Health 200, LLC · Model 34-1013D · UDI-DI 10197106772133

LRO Prescription
10
510(k) clearances
21,411
Adverse events (2 deaths)
1,070
Recalls
158
Facilities

Description

PAIN TRAY W CHLORAPREP

Recalls

DateFirmReason
2026-08-18Cardinal Health 200, LLCThe kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl
2026-08-11Medline Industries, LPThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu
2026-08-10AVID Medical, Inc.Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
2026-08-10Medline Industries, LPThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r
2026-08-10Medline Industries, LPKits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as
2026-07-31Medline Industries, LPKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o
2026-07-29Cardinal Health 200, LLCThe Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is
2026-07-23Medline Industries, LPThe kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a comprom
2026-07-22AVID Medical, Inc.Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
2026-07-22AVID Medical, Inc.Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

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.