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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Bard Access Systems Inc.: 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

Agency Publication Date: May 20, 2021
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Affected Products

Product: REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redx4723 and REEU3251

Product: 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.

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,

Product: REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. REDY1755

Product: REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. reev2091, reex1265, reew3144, redx1464, reen4697, REEP0632

Product: 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.

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

Product: 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.

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

Product: REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redr1671 reds4453 redt1612 redt2758 redt3914 redu0326 redu3286 redu3402 redu4194 redu4226 redv1248 redv2001 redv2750 redw0124 redx3813 redx3828 redy1863 redy2874 redy3867 redz0552 redz1927 redz3505 REEN1390 reen1396 reeq1509 reet2730 reet3239 reeu0563 reew2029 reex2346 reex3092 reey2704 reex3917

Product: REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. reeu1838

Product: REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. reep1720

Product: REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. reep1720 redy0653 REEN1127 REEN1905 reeq0634 rees0249 reet2073 reev1213 reew4243

Product: REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. reen4697 and reep0632

Product: REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. REDT1691, reeu3507, reew4280

Product: REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741147521 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redx4687, rees1313, reev1270

Product: REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redx0702 redx1450 redx2338 redx4128 reep0823 reeq3588 reer1040 reer3480 rees0567 rees1246 rees2299 reew1849 reew4279 reex0353 reex3469

Product: REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redx1384 reep4143 reeq1238

Product: REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redz3509 REEN4546 reep4145 reer0944 reer2048 rees1328 rees2108 rees3222 reeu1443 reeu2740 reeu3561 reew4312

Product: 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.

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

Product: REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.

Lot No. redy3816, REEP1719, REEW2787, REEX1087

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87594
Status: Resolved
Manufacturer: Bard Access Systems Inc.
Manufactured In: United States

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.