Recall Z-1618-2013— Bard Access Systems
Class II · Terminated
Class II FDA medical device recall by Bard Access Systems, initiated 2013-06-10, terminated 2014-05-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Bard Access Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-10
- Terminated
- 2014-05-21
- Firm location
- Salt Lake City, UT, United States
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.