The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2383-2018·Announced 2018-07-18

Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Labeling Issues

Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

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 and involves a labeling error (difficulty identifying lot number and expiration date) without reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Arrow International Inc. is recalling 2,070 units of the VPS Rhythm ECG Accessory Pack, reference number RHY-100-ECGO. The product is used to provide real-time tip location information for central venous catheters by utilizing ECG to observe P-wave changes as the tip approaches the right atrium of the heart. The specific lot number involved in this recall is 13F17A0288.

The recall was initiated because the product pouch label may not easily identify the lot number, expiration date, and associated symbols. This labeling deficiency could make it difficult for healthcare providers to verify product details and expiration status. The affected products were distributed nationwide in the states of Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, and Washington.

Healthcare facilities and consumers who have this specific product should stop using it and contact Arrow International Inc. for further instructions or a return. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The…
Manufacturer
Arrow International Inc
Category
Medical Device — ECG Accessories
Hazard
Affected units
2,070

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: 13F17A0288

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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