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Recall Observatory FDA recall evidence

Device 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.

Z-1732-2017

March 09, 2017

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 76730
Status
Terminated
Classification
Class II
Quantity
588 kits
Official record key
device-enforcement:Z-1732-2017

Official wording

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 information: Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016081550 4/30/19 2016080950 4/30/19 2016072250 12/31/18 2016051350 10/31/18 2016030550 4/30/18 2016022350 4/30/18 2016011850 4/30/18 2015122150 4/30/18 2015121450 4/30/18 2015101250 4/30/18 2015070750 2/28/18 2015062950 2/28/18 2015061950 1/31/18 2015062250 2/28/18 2015051850 1/31/18 2015050450 2/28/18 2015042850 11/30/17 2015031950 11/30/17 2015010750 10/31/17 2014103150 7/31/17 2014102750 7/31/17 2014073050 5/31/17

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.