Fleixiflo Quantum Enteral Pump.
FDA device recall Z-0145-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
- Action taken
- The recalling firm notified consignees by phone on 10/7/05 and followed up by letter dated 10/7/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 24 devices
- Distribution
- The device was distributed to 11 hospitals, 5 medical supply customers, and 3 nursing homes located in AL, CA, IN, LA, MI, NC, NH, NY, OH, OK, PA, SC, TN, VA, and WI.
- Date initiated
- 2005-10-07
- Date posted
- 2005-11-16
- Date terminated
- 2007-08-13
- Location
- Columbus, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIFLO QUANTUM ENTERAL PUMP (K944669) | Abbott Mfg., Inc. | 1995-07-24 |