FDA Device recall Z-1992-2012
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G0300…
- FDA Device
- Class I
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class I recall of Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G0300… by B Braun Medical, citing 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 insert….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1992-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-03-23 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
Identifiers
| code_info | Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2012%22
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