Flexiflo Quantum Enteral Pump
FDA device recall Z-0570-05 · posted 2005-03-08 · Terminated
Recall details
- Recalling firm
- Ross Products Division Abbott Laboratories
- Reason for recall
- Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
- Action taken
- The firm contacted all consignees via telephone and letter on 08/18/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 199 individual serial numbered units
- Distribution
- Products were distributed to the following states nationwide: MA, NJ, NY, PA, MD, VA, NC, SC, GA, FL, CA, TN, KY, OH, MI, SD, IL, KS, LA, AR, OK, TX, and CO.
- Date initiated
- 2004-08-18
- Date posted
- 2005-03-08
- Date terminated
- 2012-04-12
- 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 |