CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F recalled
Bard Access Systems is recalling REF 7655405J, 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-1657-2021
- 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 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - 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. redv2820 redv4093 redw0517 redw1152 redx1436 redx2421 redx4735 redy0645 redy3049 redz0252 redz0603 redz1577 redz2772 reen1196 reen2065 reen3257 reen4734 reep0839 reep1691 reeq0592 reeq1318 reeq2347 reer0515 reer1136 reer3474 rees0504 rees1461 rees2183 rees3127 reet0308 reet0816 reet2299 reeu0258 reeu1473 REEU2662 reeu3582 reev0163 reev1198 reew2878 reew3089 reew4300 reex2176 reez2355 reex3435
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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