EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders
EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders because the company failed to register as a medical device establishment or establish its own quality system.
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 describes a regulatory and quality system compliance failure (lack of registration and quality system) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders (OEM Catalog number 9-AVP2-010). The devices are sterile, single-use pouches manufactured by Aga Medical and repackaged by EXP. The recall is limited to one unit.
The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems.
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 the recalled devices and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Cardiovascular
- Affected units
- 1
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 9-AVP2-010.
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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