Z-2120-2017Class II

StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as...

Name: Z-2120-2017 StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as...
Creator: Bard Access Systems Inc.
Published: 2017-04-25
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2017-04-25 / Terminated / root cause: manufacturing process

FDA source

Bard Access Systems Inc. began a recall of StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is... on 2017-04-25. FDA classified it as Class II and gives the reason as "StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip". 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-2120-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Posted: 2017-05-19
Terminated: 2017-08-21
Recalling firm: Bard Access Systems, Inc.
Product: StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
Product code: KMK Device, Intravascular Catheter Securement
Reason for recall: StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.
Quantity in commerce: 4,500 units
Distribution: Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
Product codes and lots: Lot Number JUAQF675, Exp 2/28/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2120-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2120-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-19

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)