Arrow PSI Kit Recalled for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling 410 units of Arrow PSI Kits due to incorrect expiration dates on the product lidstock.
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: The recall is classified as FDA Class II, but the specific defect is a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Arrow International Inc. is recalling 410 units of the Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters (ASK-09801-UPM). The recall is being conducted because the product lidstock contains the incorrect expiration date for the product.
The affected units are identified by Lot Numbers 13F18G0475 and 13F18F0729. The products were distributed nationwide and in foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected kits. They should contact Arrow International Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 410
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)
- Lot Number: 13F18G0475 13F18F0729
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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 20 products in this recall →Related recalls
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