ClearanceBrief
Recall Z-1732-2017 ยท OXQ Dressing Change Tray

Centurion Medical Products Corporation

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.

DateMar 27, 2017 (initiated Mar 9, 2017)
StatusTerminated
ReasonCenturion 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 causeNonconforming Material/Component
ActionOn 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.
Quantity588 kits
DistributionUS Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.