Bard StatLock CV Plus Stabilization Devices Recalled for Assembly Error
Bard Access Systems is recalling StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly that may cause skin irritation or catheter mis-orientation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (skin irritation and catheter mis-orientation) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity rating.
Plain-English summary
Bard Access Systems is recalling 3,875 units of StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, lot JUWJF283. The recall is due to incorrect pad assembly used during manufacture.
The absence of the hydrocolloid strip on the bottom of the device may pose an incremental risk, including localized skin irritation. Additionally, a missing directional arrow may lead to mis-orientation of the StatLock stabilization, which may impact the securement of the catheter.
The affected devices were distributed nationally and globally, including in Europe, the European Economic Area, Argentina, China, and Brazil. Users should check their inventory for lot number JUWJF283 and discontinue use of the affected devices.
The recalled product
- 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.
- Manufacturer
- Bard Access Systems
- Affected units
- 3,875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot JUWJF283
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Bard Access Systems
See all →- ModerateBard Access Systems Recalls StatLock Catheter Stabilization Devices
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls PowerPICC Catheter Marketing Brochures
FDA (Devices) · 2015-09-30
Same hazard · skin irritation
See all →- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateCardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes
FDA (Devices) · 2026-09-09
- ModerateCardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes
FDA (Devices) · 2026-09-09
Similar recalls
- ModerateBard Access Systems Recalls StatLock Catheter Stabilization Devices
FDA (Devices) · 2017-01-18
- ModerateBard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
FDA (Devices) · 2017-01-18
- ModerateBard StatLock IV Premium Catheter Stabilization Device Recalled for Sizing Error
FDA (Devices) · 2017-05-31
- HighC.R. Bard Foley Catheter Kit Recall: Packaging Sterility Defect
FDA (Devices) · 2021-09-29
- HighC.R. Bard Recalls Medical Devices Containing Latex Catheters
FDA (Devices) · 2017-01-18
- HighC.R. Bard Foley Catheter Trays Recalled for Packaging Defects
FDA (Devices) · 2021-09-29