Centurion Medical Products Central line procedure kit DT12210, Sterile
FDA device recall Z-1084-2011 · posted 2011-02-09 · Terminated
Recall details
- Recalling firm
- Centurion Medical Products
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRS
- Quantity affected
- 12
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-06-02
- Date posted
- 2011-02-09
- Date terminated
- 2011-02-09
- Location
- Howell, MI
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