Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Thre...

FDA Device Recall #Z-2943-2018 — Class II — March 21, 2018

Recall Summary

Recall Number Z-2943-2018
Classification Class II — Moderate risk
Date Initiated March 21, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Medical Division
Location Covington, GA
Product Type Devices
Quantity 131,950

Product Description

Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.

Reason for Recall

Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating.

Distribution Pattern

AR, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, SC, TN, TX, UT, and WA,

Lot / Code Information

Catalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822

Other Recalls from Bard Medical Division

Recall # Classification Product Date
Z-0803-2019 Class II SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Cl... Dec 13, 2018
Z-0800-2019 Class II BARD SureStep Foley Tray System Bardex I.C. Com... Dec 6, 2018
Z-2536-2018 Class II Arctic Sun Temperature Management System, Model... Jun 13, 2018
Z-1241-2019 Class II Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: ... Nov 8, 2017

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.