Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang
FDA device recall Z-2305-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
- Action taken
- On June 27, 2008, the firm sent Important Device Recall letters to their customers. The letter instructed their customers to immediately inspect their inventory for the affected product, place it on hold, and report the information to back to them via account summary forms. Furthermore, if they are a distributor, they are required to contact their customers and notify them of this important device recall and supply them with the appropriate documentation to record the recall. Contact Abbott Nutrition, Abbott Laboratories at 1-614-624-3688 for assistance.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 57,120 units
- Distribution
- Nationwide: AR, AZ, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MO, MS, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VT, WA, WI and WY.
- Date initiated
- 2008-06-27
- Date posted
- 2008-09-20
- Date terminated
- 2012-09-19
- Location
- Columbus, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT (K915735) | Abbott Laboratories | 1992-06-24 |