510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1731-2017Class II

OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the...

Centurion Medical Products, LP / initiated 2017-03-09 / Terminated / root cause: manufacturing process

Centurion Medical Products Corporation began a recall of OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1731-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
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.
Product code
OXQ Dressing Change Tray
Reason for recall
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 tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
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.
Quantity in commerce
210 kits
Distribution
US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1731-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1730-2017Class IITerminatedVoluntary: Firm initiated
Z-1731-2017Class IITerminatedVoluntary: Firm initiated
Z-1732-2017Class IITerminatedVoluntary: Firm initiated
Z-1733-2017Class IITerminatedVoluntary: Firm initiated
Z-1734-2017Class IITerminatedVoluntary: Firm initiated
Z-1735-2017Class IITerminatedVoluntary: Firm initiated
Z-1736-2017Class IITerminatedVoluntary: Firm initiated