Z-1666-2021Class II

REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F...

Name: Z-1666-2021 REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F...
Creator: Bard Access Systems Inc.
Published: 2021-04-07
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2021-04-07 / Terminated / root cause: manufacturing process

FDA source

Bard Access Systems Inc. began a recall of REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704... on 2021-04-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1666-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-07
Posted: 2021-05-20
Terminated: 2023-06-01
Recalling firm: Bard Access Systems, Inc.
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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 7, 2021, Bard Access Systems issued a "Urgent Medical Device Recall - Correction" to affected consignees via FedEx. In addition to informing consignees about the correction, the firm ask consignees to take the following actions: 1. Share this correction notification with all users within your facility network of the product to ensure they are also aware of this recall and shipment of no charge connectors. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. Note: There is no need to discard or return product to BD. If the clinician encounters the issue described in this notification, obtain a Replacement Connector (REF# 7812400, Groshong nXt, 4Fr Connector Repair Kit). If the Replacement Connector is not available at your facility, then obtain the connector from a new 4Fr S/L Groshong nXt catheter kit. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 4. If you require further assistance, please contact: Customer/technical Support @ 1-844-823-5433, Mon-Fri: 8:30 AM - 5:00 PM CST. For customers outside US, contact your local BD representative or distributor.
Distribution: 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.
Product codes and lots: Lot No. redx1384 reep4143 reeq1238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1666-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1652-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1653-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1654-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1655-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1656-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1657-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1658-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1659-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1660-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1661-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1662-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1663-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1664-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1665-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1666-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1667-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1668-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1669-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20

Product code LJS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)