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Trial Procedure Kit
MEDIVATORS INC. · Model CPKT-103773-0013 · UDI-DI 00677964110306
MNL
Prescription
4
510(k) clearances
664
Adverse events
24
Recalls
234
Facilities
Description
Trial Procedure Kit includes Transport Pad, DUOSWIFT Squeegee Valve Brush, Double Ended Channel Cleaning Brush, Intercept Bedside Kit, Dirty Scope Label, Syringe, Bite Block, DEFENDO Valves Kit, Suction Tubing, Nasal Cannula, and Underpad.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-02 | Healthmark Industries Co., Inc. | During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their inve |
| 2025-05-02 | Healthmark Industries Co., Inc. | During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their inve |
| 2024-01-09 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 De |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2020-07-09 | Medline Industries Inc | Potential risk of brush detachment during cleaning. |
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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.