Z-0982-2017Class II

StatLock CV Plus w/Pigtail

Name: Z-0982-2017 StatLock CV Plus w/Pigtail
Creator: Bard Access Systems
Published: 2016-12-09
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2016-12-09 / Terminated / root cause: manufacturing process

FDA source

Bard Access Systems began a recall of StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending... on 2016-12-09. FDA classified it as Class II and gives the reason as "Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number...". 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-0982-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Posted: 2017-01-10
Terminated: 2017-05-26
Recalling firm: Bard Access Systems, Inc.
Product: StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Product code: KMK Device, Intravascular Catheter Securement
Reason for recall: Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Bard sent an Urgent Customer Notification letter dated December 12, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and identify any product subject to the notification. Please direct any return requests and/or questions to Shelly Gilbert at 1-800-290-1689.
Quantity in commerce: 14,500 units total
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Lot Number: JUZKF615 & JUAPF369.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0982-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09
Z-0982-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code KMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)