EXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices
EXP Pharmaceutical Services Corp is recalling Versaport Bladeless Trocar devices 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 indicates the issue is a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for minor or administrative issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling Versaport Bladeless Trocar w/ Fixation Cannula 5mm devices. These sterile, single-use medical devices are used in general and plastic surgery. The recall involves one unit of the product, identified by OEM Catalog number NB5STF.
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. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected devices were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using these devices and contact EXP Pharmaceutical Services Corp for further instructions or a return.
The recalled product
- Product
- Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery
- 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 NB5STF.
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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