Home / Recalls / Bard Access Systems Inc. / Z-1658-2021

Z-1658-2021 Class II Terminated

Recalled by Bard Access Systems Inc. — Salt Lake City, UT

FDA device recall Z-1658-2021 was initiated by Bard Access Systems Inc. on April 7, 2021 and is designated Class II. 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 connec… The recall status is terminated (terminated June 1, 2023). Affected quantity: N/A.

Recall Details

Product Type
Devices
Report Date
May 26, 2021
Initiation Date
April 7, 2021
Termination Date
June 1, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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.

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.

Code Information

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

Other recalls by Bard Access Systems Inc.

  • Z-2659-2026 Class II — 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D (May 21, 2026)
  • Z-2662-2026 Class II — CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 (May 21, 2026)
  • Z-2661-2026 Class II — 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Tr (May 21, 2026)
  • Z-2656-2026 Class II — CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 (May 21, 2026)
  • Z-2666-2026 Class II — 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 129 (May 21, 2026)
  • Z-2667-2026 Class II — CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 (May 21, 2026)
  • Z-2668-2026 Class II — 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOF (May 21, 2026)
  • Z-2658-2026 Class II — CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129 (May 21, 2026)
  • Z-2657-2026 Class II — 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI (May 21, 2026)
  • Z-2664-2026 Class II — CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741 (May 21, 2026)

FDA data resources