FDAFDA · Food and drugs·Recall number Z-1090-2018
NEONATAL IV ACCESS SET
Published March 28, 2018 · Recall initiated: October 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Centurion Medical Products Corporation
- Distributor
- Nationally
- Lot
- IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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