Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 68...
FDA Device Recall #Z-1992-2012 — Class I — March 23, 2012
Recall Summary
| Recall Number | Z-1992-2012 |
| Classification | Class I — Serious risk |
| Date Initiated | March 23, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical, Inc. |
| Location | Allentown, PA |
| Product Type | Devices |
| Quantity | 38,225 pumps |
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
Distribution Pattern
Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
Lot / Code Information
Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers.
Other Recalls from B. Braun Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1021-2025 | Class II | Design Options COMBINED SPINAL/EPIDURAL TRAY- ... | Dec 4, 2024 |
| Z-3144-2024 | Class II | AET36 ANESTH EXT SET - Anesthesia Extension Set... | Aug 8, 2024 |
| Z-2387-2024 | Class II | Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... | Jun 17, 2024 |
| Z-2380-2024 | Class II | Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE... | Jun 17, 2024 |
| Z-2391-2024 | Class II | Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE... | Jun 17, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.