EXP Pharmaceutical Services Recalls SECURESTRAP Absorbable Strap Fixation Devices
EXP Pharmaceutical Services Corp is recalling SECURESTRAP 5mm Absorbable Strap Fixation 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. The source text cites regulatory non-compliance (failure to register and maintain quality systems) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of SECURESTRAP 5mm Absorbable Strap Fixation Devices. The devices are sterile, single-use implantable straps packaged in Tyvek/Mylar pouches, with OEM Catalog number STRAP25. The recall is being conducted by the repackager, EXP Pharmaceutical Services Corp, for devices originally manufactured by Ethicon.
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. This regulatory non-compliance is the stated reason for the recall.
The affected devices were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers who have these specific devices should stop using them and contact EXP Pharmaceutical Services Corp or their supplier for instructions on return or replacement.
The recalled product
- Product
- Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 2
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 STRAP25.
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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