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.