Home › INSPIRX, INC › InspiraChamber Valved Holding Chamber
InspiraChamber Valved Holding Chamber
INSPIRX, INC · Model 1001-10SM · UDI-DI 00852367007136
NVP
Prescription
10
510(k) clearances
14
Adverse events
3
Recalls
26
Facilities
Description
InspiraChamber with SootherMask (Medium) (Teleflex Medical) 1001-10SM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-16 | Cardinal Health Inc. | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
| 2021-03-16 | Cardinal Health Inc. | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
| 2016-05-16 | FSC Laboratories, Inc | Product had torn/loose seal around the mouthpiece. |
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.