Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from
FDA device recall Z-1995-2016 · posted 2016-06-15 · Terminated
Recall details
- Recalling firm
- FSC Laboratories, Inc
- Reason for recall
- Product had torn/loose seal around the mouthpiece.
- Action taken
- Letters were sent to consignees on 5/16/2016 informing them of the recall and requesting that they immediately discontinue use of the product. The letter included a reply form to be returned to FSC Laboratories.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NVP
- Quantity affected
- 1435 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2016-05-16
- Date posted
- 2016-06-15
- Date terminated
- 2017-02-10
- Location
- Charlotte, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER (K140062) | Fsc Laboratories, Inc. | 2014-10-03 |