Centurion Medical Products Implanted access port tray DT7105, Sterile
Centurion Medical Products began a recall of Centurion Medical Products Implanted access port tray DT7105, Sterile on . The reason FDA records is "The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1075-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Centurion Medical Products Implanted access port tray DT7105, Sterile.
- Product code
- LRS I.V. Start Kit
- Reason for recall
- The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved.
- Quantity in commerce
- 528
- Distribution
- Nationwide distribution.
- Product codes and lots
- 2009100550.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
