Reported Jul 25, 2012 · Terminated
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005,…
B. Braun Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical, Inc. · 901 Marcon Boulevard · Allentown, PA · 18109-9512
Is this the product you have?
- 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.
- Lot codes and dates
- Pump Model Numbers
8713050U8713050U-998713050US8713060Uand 8713060U-99 -- various serial numbers
- Pump Model Numbers
- Amount recalled
- 38,225 pumps
Where it was sold
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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