CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report
REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F recalled
Bard Access Systems is recalling REF 7617405, 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-1668-2021
- 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 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.
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. 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
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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|---|---|---|---|---|---|
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| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |