Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1004-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

Product Classification:

Class II

Date Initiated: November 27, 2017

Date Posted: March 21, 2018

Recall Number: Z-1004-2018

Event ID: 79339

Reason for Recall:

Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

Status: Terminated

Product Quantity: 23,904 in total

Code Information:

CDA-42802-P1A CDA-42854-P1A CDA-45703-P1A 13F16K0239 13F16L0285 13F17C0318 13F16L0071 13F16M0048 13F17E0124 13F17F0497 13F17G0428 13F17H0387 13F16K0306 13F16L0091 13F17A0167 13F17B0145 13F17C0174 13F17C0466 13F17E0095 13F17F0261 13F17G0090 13F17G0541 13F17H0566 CDA-47702-P1A 13F17B0249

Distribution Pattern:

US in the states of OH, FL, SC, TX, KY, NJ, MI

Voluntary or Mandated:

Voluntary: Firm initiated