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inCourage®
Respiratory Technologies, Inc. · Model 100044-008 · UDI-DI 00841561101351
BYI
Prescription
1
510(k) clearances
282
Adverse events (6 deaths)
3
Recalls
35
Facilities
Description
Vest, Size 44, Northern Lights
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. |
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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.