Agency classClass IIOur severity:High FDA (Devices)·Z-1986-2018·Announced 2018-06-06

Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns

Arrow International Inc. is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (infection due to compromised sterility) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc. is recalling 416,055 units of the Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath. The recall involves specific product codes ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1, which are designed for use with 7.5 - 8 Fr. catheters. The affected products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.

The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the non-sterile product is used in a clinical setting. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and consumers should stop using the affected products immediately. Users should check their inventory for the specific product codes and lot numbers listed in the official recall notice. Affected units should be returned to Arrow International Inc. or disposed of according to local regulations for medical waste.

The recalled product

Product: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1
Manufacturer: Arrow International Inc
Category: Medical Device — Vascular Access
Hazard: infection
sterility-compromise
Affected units: 416,055

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 76 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 76 products in this recall →

Same manufacturer · Arrow International Inc

See all →

High
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Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
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Same hazard · infection