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ViaMed
RECE INTERNATIONAL CORPORATION · Model 13450-BLACK · UDI-DI 00811382010804
1
510(k) clearances
492
Adverse events (2 deaths)
27
Recalls
170
Facilities
Description
Deluxe chrome palm aneroid gauge, 300mm HG gauge with stethoscope. Deluxe Calibrated nylon cuff with velcro an ddurable latex bladder. Complete unit is packed in a carrying case.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-28 | Baxter Healthcare Corporation | Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2024-04-09 | GE Medical Systems Information Technologies Inc | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. |
| 2022-05-16 | Volcano Corp | Due to a potential failed sterilization process. |
| 2019-07-12 | ICU Medical, Inc. | Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, |
| 2019-06-03 | Suntech Medical, Inc. | Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package. |
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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.