EXP Recalls Chocolate Balloon Catheters Due to Registration Deficiencies
EXP Pharmaceutical Services Corp is recalling one unit of a Chocolate Balloon Catheter because the company failed to register as a medical device establishment or maintain 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, which typically indicates a temporary or medically reversible adverse health consequence. The specific hazard is a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or contamination, fitting the Moderate severity criteria for administrative or low-risk issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling one unit of the Medical Device Exchange Chocolate Ballon Catheter/Over-the-Wire. The device is a sterile, single-use angioplasty catheter manufactured by TriReme Medical and repackaged by EXP. The recall is limited to the specific OEM Catalog number CF14-150-25040-OTW.
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. This constitutes a regulatory compliance failure regarding the establishment of the repackaging facility.
The affected unit was distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers who possess this specific device should stop using it and contact EXP Pharmaceutical Services Corp for instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
- 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 CF14-150-25040-OTW.
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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