EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 devices 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, but the source text cites regulatory non-compliance (failure to register and maintain quality systems) rather than a specific product defect or reported injury. This aligns with the 'Moderate' criteria for voluntary or administrative recalls without reported harm.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 medical devices. These devices are sterile, single-use pouches used for laparoscopy in general and plastic surgery. The specific OEM catalog number for the recalled items is 179095P.
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 the fact that its vendors were registered and had their own quality systems. This regulatory non-compliance is the stated reason for the recall.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare facilities should stop using these specific devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 4
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 179095P.
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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