Medical device recalls Moderate risk

Bard Access Systems Inc. recalls StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units i…

Recall date
April 25, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2120-2017
FDA classification
Class II
Brand / firm
Bard Access Systems Inc.
Sold / distributed
Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.

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