Device 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.
Z-1618-2013
Product summary
- Event
- Event 65202
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,875 units.
- Official record key
device-enforcement:Z-1618-2013
Official wording
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
Code information: Lot JUWJF283
Distribution pattern: National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
Derived failure modes
-
Unknown
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