CRITIFLO(tm) FLUSH KIT
FDA device recall Z-0075-06 · posted 2005-10-21 · Terminated
Recall details
- Recalling firm
- Becton Dickinson Medical Systems
- Reason for recall
- Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Action taken
- Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 250 units
- Distribution
- Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..
- Date initiated
- 2005-07-01
- Date posted
- 2005-10-21
- Date terminated
- 2011-08-09
- Location
- Sandy, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRITIFLO & CRITIFLO DOME (K791844) | Gould, Inc. | 1979-10-02 |