EXP Pharmaceutical Services Recalls Angio-Seal Vascular Closure Devices
EXP Pharmaceutical Services Corp is recalling three Angio-Seal VIP Platform vascular closure 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, but the source text identifies the hazard as regulatory non-compliance (lack of registration/quality system) rather than a physical defect or contamination. Per the rubric, this aligns with 'Minor labeling errors, low-risk contamination, voluntary precautionary recalls' or administrative issues where no direct physical harm is reported.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling three units of the Angio-Seal VIP Platform/Vascular Closure Device 6F (OEM Catalog number 610130). The devices were repackaged by EXP and originally manufactured by St. Jude Medical. The recall is limited to three units distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas.
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, which does not satisfy regulatory requirements for the repackager.
Consumers and healthcare facilities that have received these specific devices should stop using them and contact EXP Pharmaceutical Services Corp for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 3
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 610130.
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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