CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering co...

FDA Device Recall #Z-0504-2024 — Class II — March 31, 2022

Recall Summary

Recall Number Z-0504-2024
Classification Class II — Moderate risk
Date Initiated March 31, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CooperSurgical, Inc.
Location Trumbull, CT
Product Type Devices
Quantity 90 units

Product Description

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

Reason for Recall

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

Distribution Pattern

Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND

Lot / Code Information

UDI-DI: 60888937016453 S/N: 309967

Other Recalls from CooperSurgical, Inc.

Recall # Classification Product Date
Z-2136-2025 Class II Endosee System Convenience Kit. Model Number: E... Jun 11, 2025
Z-2135-2025 Class II HSG Procedure Tray. Model Number: 6050T. Th... Jun 11, 2025
Z-2137-2025 Class II Endosee System Convenience Kit with IV Tube. Mo... Jun 11, 2025
Z-0687-2025 Class II Brand Name: K-Systems Product Name: G73 Dry Ba... Nov 15, 2024
Z-0688-2025 Class II Brand Name: K-Systems Product Name: G85 Mini I... Nov 15, 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.