The Recall Desk
ModerateFDA (Devices)·Z-0843-2019·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Smiths Medical ASD Inc. is recalling approximately 28,578,939 Portex Pulsator Arterial Blood Sampling Kits with Liquid Sodium Heparin. The recall involves specific models including 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 affected products have expiration dates between November 30, 2016, and May 31, 2020.

The recall was initiated because the Aplicare Povidone Iodine Prep pads packaged within these kits will not maintain the iodine potency through their labeled 36-month expiration dating. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Distribution was nationwide, including Puerto Rico, as well as military/government distribution. Foreign distribution was made to Canada, the United Arab Emirates, the Bahamas, Costa Rica, Latvia, and Saudi Arabia. Users should stop using the affected kits and contact Smiths Medical ASD Inc. for further instructions.

The recalled product

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.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Arterial Blood Sampling Kit
Hazard
Affected units
28,578,939

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product with expiration dates between 11/30/2016 and 5/31/2020.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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