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REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741...

FDA Device Recall #Z-1668-2021 — Class II — April 7, 2021

Recall Summary

Recall Number Z-1668-2021
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 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - 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. reds4650 redt0780 redt1528 redt4250 redu0070 redu0706 redu1526 REDU2456 redv1194 REDV1893 redv1894 redv2160 REDV2537 redv2538 redv2539 redv2924 redv4016 REDW0575 redw0837 redw4033 redw4034 redw4035 redw4036 redw4037 redw4038 REDW4039 redw4040 redw4042 redw4164 redw4170 redx0604 redx0743 redx0972 redx0973 redx0974 redx0975 redx0976 redx0977 redx0978 redx0979 redx0980 redx0991 redx0992 redx0993 redx0994 redx0995 redx0996 redx1339 redx1340 redx1504 redx2371 redx2483 redx4877 redy0094 redy0106 redy0107 redy0662 redy0713 redy1680 REDY2962 redz0056 redz0185 redz0664 redz0697 redz1649 redz1710 REEN1131 reen1240 reen1911 reen1982

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-1654-2021 Class II REF 7617408, Groshong NXT ClearVue Catheter, Fu... Apr 7, 2021
Z-1653-2021 Class II REF 7617405J, Groshong NXT ClearVue Catheter, B... Apr 7, 2021
Z-1661-2021 Class II REF 9617408, Groshong NXT ClearVue Catheter wit... 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.

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