EXP recalls 12 unregistered sterile dilating tip trocars
EXP Pharmaceutical Services Corp is recalling 12 sterile dilating tip trocars because the company failed to register as a medical device establishment or maintain a 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. The hazard is a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary or compliance recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 12 units of sterile, single-use Dilating Tip Trocar w/Stability Sleeve 11mm (OEM Catalog number D11LT). The devices were repackaged by EXP and 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, 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, which does not comply with FDA requirements for the repackager.
Healthcare facilities and consumers who possess these specific devices should stop using them and contact EXP Pharmaceutical Services Corp for instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 12
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 D11LT.
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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