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

FDA device recall Z-1618-2013 · posted 2013-06-28 · Terminated

Recall details

Recalling firm

Bard Access Systems

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

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

KMK

Quantity affected

3,875 units.

Distribution

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

Date initiated

2013-06-10

Date posted

2013-06-28

Date terminated

2014-05-21

Location

Salt Lake City, UT