REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)108017...
FDA Device Recall #Z-1653-2021 — Class II — April 7, 2021
Recall Summary
| Recall Number | Z-1653-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 7, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Access Systems Inc. |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | N/A |
Product Description
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason for Recall
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
Lot / Code Information
Lot No. reds3422, redt4228, redu0707, redu1364, redv1255, redv2161, redv2786, redv4057, redw0433, redw1225, redw2664, redw3833, redx2372, redx4194, redy0664, redy1758, redz0057, redz0666, redz1930, reen1132, reen3294, reen4671, reep0758, reep1721, reep2923, reep3974, reeq0638, rees0525, rees0590, reew2481, reew2485, reew2487,
Other Recalls from Bard Access Systems Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1991-2021 | Class II | 5Fr PowerPICC Catheter Single-Lumen with 70cm G... | May 19, 2021 |
| Z-1994-2021 | Class II | 5 Fr IR PowerPICC Convenience Kit Catheter Dual... | May 19, 2021 |
| Z-1652-2021 | Class II | REF 7617400, Groshong NXT ClearVue Catheter, in... | Apr 7, 2021 |
| Z-1661-2021 | Class II | REF 9617408, Groshong NXT ClearVue Catheter wit... | Apr 7, 2021 |
| Z-1666-2021 | Class II | REF CK000379, Groshong NXT ClearVue Catheter wi... | Apr 7, 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.