EXP Pharmaceutical Services Recalls Unregistered Implantable Staple Loading Units
EXP Pharmaceutical Services Corp is recalling three units of implantable staple loading units 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 driven by regulatory non-compliance (lack of registration and quality system) rather than a specific product defect or reported injury, fitting the criteria for moderate severity associated with documentation and compliance issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling three units of Medical Device Exchange Loading Units with DST Series Technology (60mm - 3.5mm). These sterile, single-use implantable staple 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.
Consumers and healthcare facilities that have received these specific units should stop using them and contact EXP Pharmaceutical Services Corp for instructions on return or disposal. The affected units are identified by OEM Catalog number TA6035L.
The recalled product
- Product
- Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
- 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 TA6035L.
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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