Bard Access Systems: Medical Device Recall in 2013 - (Recall #: Z-1618-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 10, 2013

Date Posted: July 10, 2013

Recall Number: Z-1618-2013

Event ID: 65202

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

Status: Terminated

Product Quantity: 3,875 units.

Code Information:

Lot JUWJF283

Distribution Pattern:

National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).

Voluntary or Mandated:

Voluntary: Firm initiated