Reported Feb 27, 2019 · Terminated
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- 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.
- Lot codes and dates
- Product with expiration dates between 11/30/2016 and 5/31/2020.
- Amount recalled
- Approx. 28,578,939 kits for both products
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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