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NIBP Cuffs
Philips Medical Systems Hsg · Model NEONATAL SINGLE-PATIENT NIBP CUFFS · UDI-DI 00884838008243
10
510(k) clearances
507
Adverse events (2 deaths)
27
Recalls
170
Facilities
Description
Neonatal Single-Patient NIBP Kit contains 50 Cuffs: 5 M1866B Size#1, 10 M1868B Size#2, 20 M1870B Size#3, 10 M1872B Size#4, 5 M1873B Size#5. Incorporates new connector configuration and replaces the M1820-60020.
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.