FDA Enforcement
Class II
Terminated
POST-OPERATIVE 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.
Recall: Z-1734-2017
·
Reported April 12, 2017
Enforcement
- Recall Number
- Z-1734-2017
- Event ID
- 76730
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Centurion Medical Products Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 12, 2017
- Initiation Date
- March 9, 2017
- Classification Date
- April 5, 2017
- Termination Date
- August 7, 2017
- Address
- 100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States
Description
POST-OPERATIVE 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.
Reason
Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.
Code Info
Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016020950 4/30/18 2015052650 1/31/18 2014082550 6/30/17
Distribution
US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
Quantity
45 kits