Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error
Arrow International is recalling Radial Artery Catheterization Kits 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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II recall involving a minor labeling error regarding shelf life, which fits the rubric for moderate severity as it is a documentation issue without reported injuries.
Plain-English summary
Arrow International Inc is recalling 24,192 units of Radial Artery Catheterization Kits, Model AK-04020-C. The recall is due to a labeling error regarding the shelf life of the povidone iodine prep pads included in the kits.
The povidone iodine prep pads do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. The affected lots have expiration dates ranging from October 2018 through March 2020. The products were distributed nationwide in the United States, including Puerto Rico.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be returned to the distributor or manufacturer for credit or replacement.
The recalled product
- Product
- Radial Artery Catheterization Kit; Model: AK-04020-C
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 24,192
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 (12)
- Lots: 13F16H0430
- 13F16M0224
- 13F16M0242
- 13F17F0150
- 13F17F0475
- 13F17G0240
- 23F16E1193
- 23F16F0476
- 23F16G0085
- 23F16H0013
- 23F16H0680
- 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.
See all 7 products in this recall →Related recalls
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