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Vistarmed
Shenzhen Vistar Medical Supplies Co.,Ltd. · Model Reusable blood pressure cuff · UDI-DI 96973521870001
1
510(k) clearances
507
Adverse events (2 deaths)
27
Recalls
172
Facilities
Description
1,Reusable for multi patient use 2,Compatible with most brands of patient monitors 3,Full range to fit most patient's arm from neonate to thigh 4,Easy to clean 5,Latex Free&biocompatibility tested 6,Compliance with ANSI/AAMI SP10-2002,EN60601-1:1990
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.