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Quick Pressure Monitor Set
C2DX, INC. · Model 0295-002-000 · UDI-DI 10850007350014
LXC
Prescription
1
510(k) clearances
20
Adverse events
2
Recalls
12
Facilities
Description
6/pkg. Each set includes pre-filled syringe, diaphragm chamber, and side-ported needle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-28 | MY01, INC. | There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of speci |
| 2005-07-22 | Stryker Instruments Div. of Stryker Corporation | The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user. |
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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.