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Endo-Carry-on Procedure Kit
MEDIVATORS INC. · Model 4006519 · UDI-DI 40677964034501
NWU
Prescription
3
510(k) clearances
19
Adverse events
23
Recalls
37
Facilities
Description
Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Defendo Air Water Suction and Air Water Jet Valves, Sponge, DEFENDO Cleaning Adapter, Bioshield, Transport Pad, Lubricating Jelly, Gauze, Duoswift Squeegee Brush, and Biohazard Sticker.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o |
| 2025-09-04 | American Contract Systems Inc. | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not |
| 2025-07-14 | American Contract Systems Inc | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further |
| 2025-02-11 | 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 may |
| 2025-02-06 | American Contract Systems Inc | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 | American Contract Systems Inc | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-01-31 | American Contract Systems, Inc. | Sterility assurance with procedure trays |
| 2024-11-21 | MEDLINE INDUSTRIES, LP - Northfield | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. |
| 2024-11-08 | Cardinal Health 200, LLC | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 | Cardinal Health 200, LLC | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
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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.