POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the...
Centurion Medical Products Corporation began a recall of POST-OP EYE 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-1730-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- POST-OP EYE 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
- 476 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: 2016100390 12/31/18 2016092190 12/31/18 2016072790 10/31/18 2016061590 4/30/18 2016031490 4/30/18 2016022390 4/30/18 2015111190 4/30/18 2015092890 4/30/18 2015083190 9/30/17 2015032390 10/31/17 2015052890 9/30/17 2015052090 9/30/17 2015050590 9/30/17
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1730-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1731-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1732-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1733-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1734-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1735-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1736-2017 | Class II | Terminated | Voluntary: Firm initiated |
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