Arrow International Recalls VPS Rhythm ECG Accessory Packs for Labeling Issues
Arrow International Inc. is recalling 2,070 units of 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 the hazard is a minor labeling error regarding lot numbers and expiration dates, which fits the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs with Johans Adapter (REF RHY-100-ECGJ). The recall is due to a labeling defect where the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
The affected products are distributed nationwide in the states of AR, AZ, CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA, and WA. The specific lot numbers involved are 13F17A0287 and 13F17C0018.
This device is used to provide real-time tip location information for central venous catheters by utilizing ECG to observe P-wave changes. Consumers and healthcare facilities should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ 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…
- 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 Numbers: 13F17A0287 & 13F17C0018
Distribution
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.
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