FDA Device recall Z-0842-2019
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Elect…
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Elect… by Smiths Medical Asd, citing the povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0842-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-22 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Reason
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
Identifiers
| code_info | Product with expiration dates between 11/30/2016 and 5/31/2020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0842-2019%22
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