Reported May 31, 2017 · Terminated

StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units…

Bard Access Systems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Access Systems Inc. · 605 N 5600 W · Salt Lake City, UT · 84116-3738

Is this the product you have?

  • StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile
  • Packagingpackaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices
Lot codes and dates
    • Lot Number JUAQF675
    • Exp 2/28/2019
Amount recalled
4,500 units

Where it was sold

  • Nationwide
  • VA

Why it was recalled

StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2017 · Data as of Sep 19, 4:46 PM UTC

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