B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antib...
FDA Device Recall #Z-0921-2014 — Class II — December 13, 2013
Recall Summary
| Recall Number | Z-0921-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 13, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical, Inc. |
| Location | Allentown, PA |
| Product Type | Devices |
| Quantity | 30, 240 units |
Product Description
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Reason for Recall
Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.
Distribution Pattern
US Distribution one importer/wholesale distributor in MO.
Lot / Code Information
Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.
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.