Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

FDA Device Recall #Z-0577-2022 — Class II — January 7, 2022

Recall Summary

Recall Number Z-0577-2022
Classification Class II — Moderate risk
Date Initiated January 7, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corporation
Location Deerfield, IL
Product Type Devices
Quantity 58,194 units

Product Description

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Reason for Recall

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

Distribution Pattern

Worldwide

Lot / Code Information

All lot numbers within expiry

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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.