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Smith & Nephew, Inc. · Model 7211010S3E · UDI-DI 00885554030822
HRX
Prescription
10
510(k) clearances
25,912
Adverse events (36 deaths)
126
Recalls
389
Facilities
Description
DYONICS 25 FLUID MANAGEMENT CONTROL UNIT SERVICE REPLACEMENT THIRD EDITION CONTROL UNIT ONLY
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2024-10-11 | Karl Storz Endoscopy | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. |
| 2024-05-24 | WOM World Of Medicine AG | Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery |
| 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 |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-01-19 | ReNovo, Inc. | Non-sterile product was shipped to customers labelled as sterile. |
| 2020-06-24 | Smith & Nephew, Inc. | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve |
| 2020-04-24 | Medtronic Sofamor Danek USA Inc | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may incre |
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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.