Z-1618-2013Class II

StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The...

Name: Z-1618-2013 StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The...
Creator: Bard Access Systems
Published: 2013-06-10
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2013-06-10 / Terminated / root cause: packaging

FDA source

Bard Access Systems began a recall of StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible... on 2013-06-10. FDA classified it as Class II and gives the reason as "BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1618-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2013-06-28
Terminated: 2014-05-21
Recalling firm: Bard Access Systems, Inc.
Product: StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.
Product code: KMK Device, Intravascular Catheter Securement
Reason for recall: BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet
Root cause tag: packaging
FDA root cause: Packaging
Action: On 6/18/13, an "Urgent Kit Recall" notification letter was mailed to all customers informing them of the recall and instructing the consignee to remove and return any affected product lot numbers to Bard Access Systems through return goods authorization. Customers may contact 800-290-1689 if questions.
Quantity in commerce: 3,875 units.
Distribution: National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
Product codes and lots: Lot JUWJF283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1618-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1618-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-06-28

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)