Centurion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach
Centurion Medical Products is recalling 210 ophthalmic dressing kits due to a potential breach in the sterile packaging of the included eye pads.
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 is classified as FDA Class II and involves a potential breach in sterile packaging for a medical device, which poses a risk of harm (infection) even though no specific injuries are reported in the text.
Plain-English summary
Centurion Medical Products Corporation is recalling 210 Centurion Convenience Kits. These kits contain individually packaged and sterilized Covidien Curity Oval Eye Pads, which are placed into non-sterile 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 specific batch numbers and expiration dates involved are 2016081750 (4/30/19), 2016080450 (12/31/18), 2016060250 (10/31/18), 2015091050 (4/30/18), 2015090350 (4/30/18), 2015083150 (4/30/18), 2015012750 (10/31/17), 2015012250 (10/31/17), and 2014061850 (4/30/17). The products were distributed in New York, North Carolina, Pennsylvania, California, Ohio, Washington, Virginia, New Jersey, and Illinois.
Healthcare facilities and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a return.
The recalled product
- Product
- OPHTHALMIC DRESSING 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
- Affected units
- 210
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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