FDA Medical devices recall ·
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit recall
- Recall number
- Z-1915-2026
- Date
- (initiated March 11, 2026)
- Company / brand
- Arrow International, LLC
3015 Carrington Mill Blvd, Morrisville, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied
Why was it recalled?
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 Batch Number: 33F25M0011 Product Code: ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 Batch Number: 33F25L0143 Product Code: ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 Batch Number: 33F25L0144 Product Code: ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 Batch Number: 33F25L0145
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
States: Arizona California Georgia Massachusetts Maine Michigan Oregon Pennsylvania Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1915-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.