Arrow International Recalls Midline Catheter Kits Due to Labeling Issues
Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits 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 minor labeling error where specific product details are not easily identified, fitting the rubric for moderate severity.
Plain-English summary
Arrow International Inc is recalling 2,070 units of Peripherally Inserted Midline Catheter Kits with Placement Wire (REF MK-02031-TW, Lot Number 13F16M0102). The recall was initiated because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
The affected products were distributed nationwide in the United States, specifically 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. These devices are used to provide real-time tip location information for central venous catheters by utilizing ECG to observe P-wave changes.
Healthcare facilities and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW 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…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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: 13F16M0102
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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