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ChemoPlus
Cardinal Health 200, LLC · Model CT5502TS · UDI-DI 10885380172403
10
510(k) clearances
780
Adverse events
129
Recalls
225
Facilities
Description
ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Sterile
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-28 | Medline Industries, LP | Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in p |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag |
| 2025-11-12 | Cardinal Health 200, LLC | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. |
| 2023-11-29 | MEDLINE INDUSTRIES, LP - Northfield | Surgical gowns were manufactured with the wrong sleeve. |
| 2022-10-31 | Owens & Minor Distribution, Inc. | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection |
| 2022-09-01 | Texas Medical Technology Inc. | Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., bloo |
| 2021-11-02 | Cardinal Health | Potential for open packaging seals compromising the sterility of the surgical gowns |
| 2021-11-02 | Cardinal Health | Potential for open packaging seals compromising the sterility of the surgical gowns |
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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.