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.
Reported: February 27, 2019 Initiated: June 22, 2018 #Z-0843-2019
Product Description
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- Approx. 28,578,939 kits for both products
- Distribution
- Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahamas, Costa Rica, Latvia, and Saudi Arabia.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smiths Medical ASD Inc.. Units affected: Approx. 28,578,939 kits for both products.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2019. Severity: Moderate. Recall number: Z-0843-2019.
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