Home › WESTMED, INC. › Vibralung Patient Kit with Circulair II Model 0295
Vibralung Patient Kit with Circulair II Model 0295
WESTMED, INC. · Model 9605-10 · UDI-DI 00709078001505
BYI
Prescription
1
510(k) clearances
283
Adverse events (6 deaths)
3
Recalls
35
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-31 | Smiths Medical ASD Inc. | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| 2017-09-15 | HILL-ROM MANUFACTURING, INC. | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subje |
| 2014-11-13 | Aptalis Pharmatech Inc. | Customer notification that the device may be difficult to open or close. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.