—#154049

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.

FDA product code: OXQ — Dressing Change Tray
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 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 2014061850 4/30/17

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On March 9, 2017 Centurion Medical Products recalled specific lots of medical convenience kits due to a supplier initiated recall of Covidien Curity Eye Pads. All affected customers were notified, advised to discontinue use of associated kits, and requested to confirm the status of remaining stock to Centurion.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

Timeline

Recall initiated: 2017-03-09
Posted by FDA: 2017-03-27
Terminated: 2017-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154049. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.