Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1158-2018·Announced 2018-03-28

Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

Arrow International is recalling 18,124 percutaneous sheath introducer kits because they lack required central line insertion checklists and procedure notes.

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. The hazard involves missing documentation (checklists) rather than a physical defect or contamination, which aligns with the rubric for minor labeling/documentation issues or low-risk contamination.

Plain-English summary

Arrow International Inc. is recalling 18,124 units of the Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions. These kits are designed for use with 7.5 - 8 Fr. catheters to permit venous access and catheter introduction to the central circulation. The affected products were distributed nationwide.

The recall was initiated because the products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist. These documents are tools intended to guide clinicians in the use of best practices during central line insertions. The specific lot codes associated with this recall are ASK-09903-ECL, 23F16H0387, and 23F16H0595.

Healthcare facilities and users should check their inventory for these specific lot codes. If the products are found, they should be removed from use and returned to Arrow International Inc. according to the company's instructions.

The recalled product

Product: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Manufacturer: Arrow International Inc
Category: Medical Device — Vascular Access
Hazard: missing-documentation
Affected units: 18,124

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)

ASK-09903-ECL 23F16H0387 23F16H0595

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Same manufacturer · Arrow International Inc

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Same hazard · missing documentation