Recall Z-2655-2014 ยท MEB Pump, Infusion, Elastomeric
B. Braun Medical, Inc.
B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
| Date | Sep 16, 2014 (initiated Aug 6, 2014) |
| Status | Terminated |
| Reason | The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100. |
| Root cause | Labeling Change Control |
| Action | B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees. |
| Quantity | 8,640 units |
| Distribution | Distributed in the state of Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP Westmed, Inc., Jul 15, 2008 |