FDA Device recall Z-1090-2018
NEONATAL IV ACCESS SET
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of NEONATAL IV ACCESS SET by Centurion Medical Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1090-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-23 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Centurion Medical Products |
| Distribution | n/a |
Product
NEONATAL IV ACCESS SET
Reason
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.
Identifiers
| code_info | IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1090-2018%22
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