CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report
StatLock CV Plus w/Pigtail, Catheter Stabilization Device recalled
Bard Access Systems is recalling StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R, distributed nationwide in the US. The recall was initiated on 10 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1618-2013
- FDA event ID
- 65202
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2013
- FDA classified
- 28 Jun 2013
- Reported
- 10 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 10 Jun 2013 | Recall initiated by company | |
| 28 Jun 2013 | Classified by FDA | +18 days |
| 10 Jul 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
Questions about this recall
Is StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R recalled?
Yes. Bard Access Systems recalled StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R on 10 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1618-2013.
Why was it recalled?
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
Which lots are affected?
Lot JUWJF283
Where was it sold?
National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heart & Vascular Devices recalls
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |