Bard Access Systems Inc.: Medical Device Recall in 2021 - (Recall #: Z-1667-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: April 7, 2021
Date Posted: May 26, 2021
Recall Number: Z-1667-2021
Event ID: 87594
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

Status: Terminated
Product Quantity: N/A
Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated