Recall Z-0623-2013 ยท FRN Pump, Infusion
B. Braun Medical, Inc.
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
| Date | Dec 31, 2012 (initiated Mar 23, 2012) |
| Status | Terminated |
| Reason | Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps. |
| Root cause | Device Design |
| Action | B. Braun Medical, Inc sent an Urgent Medical Device letter dated March 23, 2012 , to all affected customers. The letter identified the product the problem and the action needed by the customer to take. B. Braun has implemented an improvement to the pump locking mechanism of t he older style pole clamps and will be upgrading any older style pole clamps that may remain within your facility. Please return the completed form from attachment 1 in the self-addressed envelope provided or fax the form to (610) 849-1197 within two (2) weeks of receipt\. If you require any additional information or |
| Quantity | 13,078 |
| Distribution | Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN. |
| FDA record | Open on fda.gov |