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Recall Observatory FDA recall evidence

Device 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

Z-1915-2026

March 11, 2026

Class II

Product summary

Firm
ARROW INTERNATIONAL, LLC
Event
Event 98618
Status
Ongoing
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1915-2026

Official wording

Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Code information: 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 pattern: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured