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Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 ...

FDA Device Recall #Z-0978-2020 — Class II — January 4, 2019

Recall Summary

Recall Number Z-0978-2020
Classification Class II — Moderate risk
Date Initiated January 4, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Inc.
Location Bloomington, IN
Product Type Devices
Quantity 13388 total

Product Description

Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726

Reason for Recall

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Distribution Pattern

Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Lot / Code Information

8078013 8172113 8001369 8183381 NS7994828 8147249 8417607 8600625 NS8417608 NS7990886 7990888 8594598 8594599 8056338 8018675 8056337 8629502 NS8018677 NS8053511 NS8417612 NS8011064 NS8417614 NS8417615 7998415 8147267 8187145 8008415 8011065 8078026 8008416 8078027 8078028 8150465 8180873 8008417 8033600 8427840 8427841 8507952 8507953 8507954 8507955 7990900 8003104 NS7990899 7998422 7998423 8047039 8056331 8066970 8066972 8066973 8066974 8147295 8147296 8421552 8427843 8427847 8594610 7994831 8008426 8056327 8066976 8066977 8207795 8629522 NS8026827 NS8030272 NS8421563 NS8421564 NS8421566 NS8421567 8599661 8421568 NS8599665 NS8060481 NS8033606 NS8629506 NS8629507 NS8008428 NS8421571 NS8421572 NS8599666 NS8599667 NS8147321 NS8421573 NS8008429

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Z-0222-2022 Class II Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... Oct 8, 2021
Z-0223-2022 Class II Transseptal Needle with Catheter. RPN TSN-17-75... Oct 8, 2021

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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