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Recall Observatory FDA recall evidence

Device product

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.

Z-1734-2017

March 09, 2017

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 76730
Status
Terminated
Classification
Class II
Quantity
45 kits
Official record key
device-enforcement:Z-1734-2017

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: 2016020950 4/30/18 2015052650 1/31/18 2014082550 6/30/17

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.