Arrow Arterial Access Tray Recall for Povidone Iodine Shelf Life Labeling
Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.
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, but the source text identifies the issue as a shelf-life labeling discrepancy rather than a defect causing reported injuries or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Arrow International Inc is recalling 1,190 units of the Arterial Access Tray, introducer catheter, Model GU-04020. The recall is due to a labeling issue where the povidone iodine prep pads included in the kits do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
The affected lots are 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, and 23F16G0675, with expiration dates ranging from October 2018 through March 2020. These products were distributed nationwide in the United States, including Puerto Rico.
The FDA has classified this as a Class II recall. Healthcare facilities and consumers should check their inventory for these specific lot numbers and expiration dates. If found, the products should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Arterial Access Tray, introducer catheter; Model: GU-04020
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1,190
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 (8)
- Lots: 13F17A0292
- 13F17C0309
- 13F17E0359
- 13F17G0300
- 13F17J0242
- 23F16F0623
- 23F16G0675
- Expiration dates: October 2018 through March 2020
Distribution
Part of a larger recall action
This product is one of 7 recalled by Arrow International 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.
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