FSC Laboratories Recalls Flexichamber Holding Chambers Due to Seal Defects
FSC Laboratories is recalling 1,435 Flexichamber Anti-Static Valved Collapsible Holding Chambers because the seal around the mouthpiece was torn or loose.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (torn/loose seal) is a quality issue that may affect medication delivery but does not involve high-risk pathogens or reported serious injuries, fitting the Moderate criteria for minor defects or low-risk issues.
Plain-English summary
FSC Laboratories, Inc. is recalling 1,435 units of the Flexichamber Anti-Static Valved Collapsible Holding Chamber. This device is used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers (pMDIs). The recall was initiated because the product had a torn or loose seal around the mouthpiece.
The affected units were distributed nationwide in the United States. The specific lots involved are Lot 5295 (trade) with NDC 13551-901-01, and Lots 5313 (demonstration units) and 5325 with NDC 13551-902-01.
Consumers who possess these specific lots should stop using the device and contact FSC Laboratories, Inc. for further instructions or a replacement.
The recalled product
- Product
- Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
- Manufacturer
- FSC Laboratories, Inc
- Affected units
- 1,435
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 5295 (trade) NDC 13551-901-01
- Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
Distribution
Distributed nationwide across the United States.
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