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26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

FDA Device Recall #Z-2343-2018 — Class II — June 4, 2018

Recall Summary

Recall Number Z-2343-2018
Classification Class II — Moderate risk
Date Initiated June 4, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B. Braun Medical, Inc.
Location Allentown, PA
Product Type Devices
Quantity 12320

Product Description

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

Reason for Recall

There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.

Distribution Pattern

The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.

Lot / Code Information

0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548645, 0061555100, 0061555101, 0061555102, 0061556350, 0061557521, 0061559077, 0061559628, 0061559631, 0061559852, 0061559853, 0061559854, 0061560830, 0061560831, 0061562493, 0061562494, 0061562941, 0061563541, 0061564175, 0061564176, 0061564177, 0061564179, 0061564180, 0061564431, 0061564669, 0061564670, 0061564672, 0061564673, 0061566362, 0061566363, 0061567272, 0061567809, 0061567810, 0061567811, 0061567812, 0061567813, 0061567814, 0061571324, 0061571325, 0061571326, 0061571327, 0061572464, 0061572465, 0061572466, 0061572980, 0061572981, 0061572982, 0061572983, 0061572984, 0061572985, 0061572987, 0061579647, 0061579648, 0061579651, 0061579653, 0061579654, 0061581522, 0061581585, 0061581586, 0061581590, 0061581599, 0061581602, 0061581603, 0061581982, 0061581983, 0061581984, 0061581985, 0061581986, 0061581987, 0061581988, 0061583281, 0061583282, 0061583283, 0061586220, 0061586221, 0061586222, 0061586223, 0061586224, 0061586712, 0061586713, 0061586714, 0061587151, 0061587152, 0061587153, 0061587154, 0061587155, 0061587156, 0061587157, 0061587720, 0061590070, 0061591603, 0061591618, 0061591646, 0061591660, 0061591662, 0061591663, 0061591664, 0061591665, 0061591667, 0061591675, 0061594365, 0061594366, 0061594367, 0061594368, 0061594369, 0061599040, 0061599159, 0061599160, 0061599161, 0061599162, 0061599163, 0061599164, 0061599165, 0061603919, 0061603920, 0061603921, 0061608039, 0061614625, 0061614626, 00VL559752

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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.

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