Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps
FDA device recall Z-0623-2013 · posted 2012-12-31 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
- Action taken
- 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 have any questions, comments or concerns please contact your B. Braun Medical Customer Service at 800-627-7867.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 13,078
- Distribution
- Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
- Date initiated
- 2012-03-23
- Date posted
- 2012-12-31
- Date terminated
- 2015-02-02
- Location
- Allentown, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K083689) | B.Braun Medical, Inc. | 2009-07-01 |
| INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K062700) | B.Braun Medical, Inc. | 2006-10-26 |