The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-1237-2020·Announced 2020-02-26

Arrow FlexTip Plus Epidural Catheterization Kit Recalled for Incorrect Expiration Date

Arrow International Inc is recalling Arrow FlexTip Plus Epidural Catheterization Kits 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation/packaging issue (incorrect expiration date on lidstock) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.

Plain-English summary

Arrow International Inc is recalling Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC. The recall is being conducted because the product lidstock contains the incorrect expiration date for the product.

The affected lot number is 13F18B0063. The product was distributed nationwide and in foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.

Healthcare providers and consumers should stop using the recalled product and contact Arrow International Inc for further instructions or a replacement.

The recalled product

Product
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC

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: 13F18B0063

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 →

Similar recalls