Recall Z-1992-2012— B. Braun Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by B. Braun Medical, Inc., initiated 2012-03-23, terminated 2014-11-03. It names 2 FDA 510(k) clearances: K083689, K062700. Product: Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.. Reason: Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of t.
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-03-23
- Terminated
- 2014-11-03
- 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
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
Reason for recall
Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of t
Data sourced from openFDA. This site is unofficial and independent of the FDA.