The Recall Desk

FDA (Devices) recall action 80829

Smiths Medical ASD Inc. recalled 2 products on 2019-02-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-02-27
Critical
0
Units
57,157,878

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads

    Smiths Medical ASD Inc. is recalling arterial blood sampling kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    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…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits Due to Iodine Potency

    Smiths Medical ASD Inc. is recalling Portex Pulsator Arterial Blood Sampling Kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    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.…
    Category
    Distribution
    1 state