The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2233-2015·Announced 2015-08-05

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard
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

Distributed in 6 states:

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.

See all 42 products in this recall →

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