EXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices
EXP Pharmaceutical Services Corp is recalling two units of tracheal stent sizing devices due to regulatory non-compliance regarding establishment registration and quality systems.
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. The source text identifies a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported injury, aligning with the 'Moderate' criteria for low-risk or administrative issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of the Aerosizer Stent Sizing Device, a sterile, single-use medical device used for tracheal stents. The product is identified by OEM Catalog number 90129-501 and was repackaged by EXP from Merit Medical.
The recall was initiated because EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system. Instead, the company relied on the fact that its vendors were registered and had their own quality systems. This constitutes a regulatory non-compliance issue.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using these devices and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Tracheal Stent
- Affected units
- 2
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 (1)
- OEM Catalog number 90129-501.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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