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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SBA69PTCMA · UDI-DI 10197106935569
OFQ
Prescription
0
510(k) clearances
5
Adverse events
8
Recalls
21
Facilities
Description
PAIN TRAY
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | Cardinal Health 200, LLC | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o |
| 2025-10-10 | Medline Industries, LP | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inad |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical 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 |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical 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 |
| 2023-11-29 | American Contract Systems, Inc. | During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu |
| 2023-08-16 | Cardinal Health 200, LLC | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-02-25 | Stradis Medical, LLC dba Stradis Healthcare | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. |
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Get your free API keyRead the docsData 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.