Arrow International Recalls VPS TipTracker Stylet Accessory Due to Labeling Issues
Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and labeling issue (difficulty identifying lot number and expiration date) without reported injuries, illnesses, or functional device failures.
Plain-English summary
Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory (REF RHY-177-TTSAP). 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 product is a medical device accessory used to provide real-time tip location information for central venous catheters by utilizing ECG to observe P-wave changes. The device is intended for catheter placement in the lower one-third of the Superior Vena Cava (SVC) near the cavo-atrial junction. The specific lot number for the recalled units is 13F17G0074.
The product was distributed nationwide in the United States, specifically 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. Users should check their inventory for this specific lot number and contact Arrow International Inc. for further instructions.
The recalled product
- Product
- VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP 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). T
- Manufacturer
- Arrow International Inc
- 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: 13F17G0074
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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