Centurion Convenience Kits Recalled for Potential Sterile Packaging Breach
Centurion Medical Products is recalling 588 Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 588 Centurion Convenience Kits. These kits contain individually packaged and sterilized Covidien Curity Oval Eye Pads, which are placed into non-sterile Centurion Convenience Kits along with other components.
The recall is being conducted due to a supplier's recall regarding 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 covers specific batch numbers and expiration dates, including batches expiring as late as April 30, 2019.
The affected kits were distributed in New York, North Carolina, Pennsylvania, California, Ohio, Washington, Virginia, New Jersey, and Illinois. Consumers and healthcare facilities should stop using the affected kits and contact Centurion Medical Products for further instructions.
The recalled product
- Product
- OPHTHALMIC DRS TRAY 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 — Ophthalmic
- Affected units
- 588
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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