Recall Z-1995-2016 ยท NVP Holding Chambers, Direct Patient Interface
FSC Laboratories, Inc
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
| Date | Jun 15, 2016 (initiated May 16, 2016) |
| Status | Terminated |
| Reason | Product had torn/loose seal around the mouthpiece. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1435 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER Fsc Laboratories, Inc., Oct 3, 2014 |