FDA Device recall Z-1995-2016
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Me…
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Me… by Fsc Laboratories, citing product had torn/loose seal around the mouthpiece.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1995-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-16 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fsc Laboratories |
| Distribution | US |
Product
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Reason
Product had torn/loose seal around the mouthpiece.
Identifiers
| code_info | Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.