Arrow FlexTip Plus Epidural Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 205 units of the FlexTip Plus Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
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 minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.
Plain-English summary
Arrow International Inc. is recalling 205 units of the Arrow FlexTip Plus(R) Epidural Catheterization Kit, model ASK-05500-CAN. The recall is due to a labeling error where the product lidstock contains the incorrect expiration date for the product.
The affected lot number is 13F18K0740. The products were distributed nationwide and in foreign countries including Austria, Australia, Germany, Canada, Czech Republic, Guatemala, New Zealand, Poland, Slovakia, and South Africa.
Consumers and healthcare facilities should stop using the affected products and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 205
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: 13F18K0740
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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