Home / Recalls / Bard Access Systems Inc. / Z-1661-2021

Z-1661-2021 Class II Terminated

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

FDA device recall Z-1661-2021 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 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.

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. reep1720 redy0653 REEN1127 REEN1905 reeq0634 rees0249 reet2073 reev1213 reew4243

Other recalls by Bard Access Systems Inc.

  • Z-2655-2026 Class II — OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG12 (May 21, 2026)
  • Z-2664-2026 Class II — CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741 (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-2659-2026 Class II — 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D (May 21, 2026)
  • Z-2656-2026 Class II — CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 (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-2657-2026 Class II — 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI (May 21, 2026)
  • Z-2662-2026 Class II — CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 (May 21, 2026)
  • Z-2667-2026 Class II — CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 (May 21, 2026)

FDA data resources