Recall Z-0623-2013— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2012-03-23, terminated 2015-02-02. It names 2 FDA 510(k) clearances: K083689, K062700. Product: 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.. Reason: Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-03-23
- Terminated
- 2015-02-02
- Firm location
- Allentown, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K083689 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K062700 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.