| Class 2 Device Recall Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag | |
Date Initiated by Firm | June 27, 2008 |
Date Posted | September 20, 2008 |
Recall Status1 |
Terminated 3 on September 19, 2012 |
Recall Number | Z-2305-2008 |
Recall Event ID |
48725 |
510(K)Number | K915735 |
Product Classification |
Infusion pump - Product Code LZH
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Product | Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag
The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients. |
Code Information |
List #50604 Lot #47822RY Use By DEC 2009 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 625 Cleveland Ave Columbus OH 43215-1754
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For Additional Information Contact | Randal P. McKay 614-624-3688 |
Manufacturer Reason for Recall | Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set." |
FDA Determined Cause 2 | Labeling mix-ups |
Action | 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LZH
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