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.
This recall has been terminated (originally issued June 28, 2013).
- Company
- Bard Access Systems
- Recall Initiated
- June 10, 2013
- Posted
- June 28, 2013
- Terminated
- May 21, 2014
- Recall Number
- Z-1618-2013
- Quantity
- 3,875 units.
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
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
Distribution
National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
Lot / Code Info
Lot JUWJF283
Root Cause
Packaging
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.