Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator… — Class II medical device recall Z-0843-2019
Terminated recall by Smiths Medical ASD Inc., reported 2019-02-27, distributed nationwide. The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine pote
| Recall number | Z-0843-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-06-22 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BS, CA, CR, LV, SA |
| Quantity | 28,578,939 kits |
| Reason classes | labeling, potency |
| Model numbers | 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, G1806 |
Product
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0843-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.