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Endo-Carry-on Procedure Kit
MEDIVATORS INC. · Model 4007493 · UDI-DI 40677964036062
NWU
Prescription
3
510(k) clearances
19
Adverse events
23
Recalls
37
Facilities
Description
Endo Carry-on Procedure Kit includes Bedside Cleaning Kit, Enzymatic Sponge, DEFENDO Cleaning Adapter, Bioshield, Transport Pad, Lubricant, Gauze Pads, 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.