Agency classClass IIOur severity:High FDA (Devices)·Z-1981-2018·Announced 2018-06-06

Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization 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 involves a medical device where sterility is compromised, creating a risk of infection. This fits the 'High' severity criterion 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 Pressure Injectable Multi-Lumen Central Venous Catheterization Kit. The recall involves product codes ASK-15703-PVH and ASK-15703-PNYP. The specific lot numbers affected are 13F17D0024, 13F17E0454, 13F17G0083, 13F17H0048, 13F17J0096, 13F17K0195, 13F17L0138, 13F17L0679, and 13F17H0123.

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 affected products were distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, the Netherlands, New Zealand, Panama, the Philippines, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, and the United Kingdom. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or disposal.

The recalled product

Product: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
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 →

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Same hazard · infection