Recall Z-0921-2014 ยท MEB Pump, Infusion, Elastomeric
B. Braun Medical, Inc.
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
| Date | Feb 3, 2014 (initiated Dec 13, 2013) |
| Status | Terminated |
| Reason | Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications. |
| Root cause | Process design |
| Action | B. Braun Medical sent an Urgent Medical Device Recall letter dated December 13, 2013 to affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to Progressive Medical Inc., the Importer and B. Braun's sole customer. WHAT ACTIONS SHOULD I TAKE? 1. Further use and/or distribution of the affected product should be discontinued immediately. Please identify and quarantine any impacted materials in your possession. 2. Review this recall notification in its entirety and ensure that all users within your organization |
| Quantity | 30, 240 units |
| Distribution | US Distribution one importer/wholesale distributor in MO. |
| 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 |