Centurion Convenience Kits Recalled Due to Sterile Packaging Breach
Centurion Medical Products is recalling 540 Convenience Kits containing eye pads due to a potential breach in sterile packaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach in sterile packaging for a medical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 540 Custom Cadaver Kits, also known as Centurion Convenience Kits. These kits contain individually packaged and sterilized Covidien Curity Oval Eye Pads along with other non-sterile components.
The recall is being conducted because the supplier reported a potential breach in the sterile packaging of the eye pads. The affected products were placed into the kits between July 2013 and January 2017.
The recall affects distribution in New York, North Carolina, Pennsylvania, California, Ohio, Washington, Virginia, New Jersey, and Illinois. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 540
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)
- Centurion component code 2841
Distribution
Part of a larger recall action
This product is one of 7 recalled by Centurion Medical Products Corporation 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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