Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3200-2018·Announced 2018-09-26

Arrow International Recalls PICC Kits Due to Incorrect Catheter Type

Arrow International is recalling 5.5 Fr x 5.5 Fr x 40 cm double-lumen PICC Kits because they may contain the wrong catheter type, potentially delaying treatment.

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, but the source text explicitly states the issue may cause a delay in treatment rather than direct injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Arrow International Inc is recalling 1,257 units of 5.5 Fr x 40 cm double-lumen PICC Kits, Product Code CDC-44052-VPS2. The recall was initiated because the kits may contain the incorrect catheter type.

Specifically, kits intended to contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter, and kits intended to contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This discrepancy may cause a delay in treatment while a replacement catheter is obtained.

The affected products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA. The specific lot codes involved are 23F17K0753 and 23F17L0299. Healthcare providers and consumers should check their inventory for these product codes and contact the manufacturer for replacement units.

The recalled product

Product: 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: mis-labeling
treatment-delay
Affected units: 1,257

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 (2)

23F17K0753
23F17L0299

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Arrow International Inc

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Same hazard · mis labeling