Flexichamber Anti-Static Valved Collapsible Holding Chamber — Class II medical device recall Z-1995-2016
Terminated recall by FSC Laboratories, Inc, reported 2016-06-22, distributed nationwide. Product had torn/loose seal around the mouthpiece.
| Recall number | Z-1995-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | FSC Laboratories, Inc, Charlotte, NC, United States |
| Recall initiated | 2016-05-16 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,435 units |
| Reason classes | packaging |
| NDC | 13551-0901-01, 13551-0902-01 |
| Lot numbers | 5295, 5313 |
Product
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Reason for recall
Product had torn/loose seal around the mouthpiece.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1995-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.