The Recall Desk
ModerateFDA (Devices)·Z-1245-2020·Announced 2020-02-26

Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

Arrow International Inc. is recalling 870 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a labeling error (incorrect expiration date) without reported injuries, fitting the Moderate severity criteria for minor labeling errors.

Plain-English summary

Arrow International Inc. is recalling 870 units of the Arrow Epidural Catheterization Kit, model AK-05000. The recall was initiated because the product lidstock contains the incorrect expiration date for the product.

The affected units are identified by Lot Number 13F18A0451. The product was distributed nationwide and in foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.

Consumers and healthcare providers should stop using the affected product and contact Arrow International Inc. for further instructions or a replacement.

The recalled product

Product
Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
Affected units
870

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: 13F18A0451

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 →