CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F recalled
Bard Access Systems is recalling REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, distributed nationwide in the US. The recall was initiated on 7 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1656-2021
- FDA event ID
- 87594
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2021
- FDA classified
- 20 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 7 Apr 2021 | Recall initiated by company | |
| 20 May 2021 | Classified by FDA | +43 days |
| 26 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
Where it was distributed
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.
Nationwide AlaskaAlabamaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMinnesotaMissouriMontanaNorth CarolinaNorth DakotaNebraskaNew Hampshire
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot No. reds2369 reds3369 reds4464 reds4588 redt0655 redt0787 redt1710 redt1760 redt2668 redt2909 redt4286 redt4309 redu0080 redu0745 redu0826 redu0827 redu1375 redu1533 redu2186 redu2403 redu2995 redu3073 redu3829 redu3920 redv1130 redv1285 REDV2022 redv2095 redv2812 redv2886 redv3944 REDV4092 REDW0350 REDW0460 redw1019 redw1151 redw1668 redw1669 redw1695 redw2471 redw2592 redw3754 redx0981 redx0982 redx0984 redx0985 redx0986 redx0987 redx1000 redx1001 REDX1002 redx1003 redx4676 redy0095 redy0096 redy0108 redy0109 redy0644 redy0703 REDZ0125 redz0433 redz1593 redz2836 redz3691 redz3692 redz3694 reen1167 reen1970 reen1971 reen3067 reen3286 reen4660 reen4733 reen5319 reep0814 reep1710 reeq2360 reeq2384 reeq2507 reeq2508 REDX3652 redy3370 REEQ2519
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 87594This product is part of a recall event; the main page for the event is REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F recalled.
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|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |