EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
EXP Pharmaceutical Services Corp is recalling a medical device exchange product 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, but the source text explicitly states that the hazard is administrative (lack of registration/quality system) and does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling a medical device exchange product, specifically a PT WIRE 300 guide wire and sterile pouch, manufactured by Boston Scientific. The product is identified by OEM Catalog number 38931-04. 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 its vendors being registered and having their own quality systems.
The affected products were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers and healthcare facilities should stop using the affected products and contact EXP Pharmaceutical Services Corp or their supplier for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
- Manufacturer
- EXP Pharmaceutical Services Corp
- 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 38931-04.
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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