Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
4FR Single Lumen Pressure Injectable PICC Recalled by Arrow International Inc Due to Labeling inaccuracy in the Instructions for Use (IFU)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected Products
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Quantity: 31590
Why Was This Recalled?
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report