Arrow International Inc: Medical Device Recall in 2015 - (Recall #: Z-0207-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

Product Classification:

Class II

Date Initiated: October 16, 2015

Date Posted: November 11, 2015

Recall Number: Z-0207-2016

Event ID: 72463

Reason for Recall:

Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

Status: Terminated

Product Quantity: 12,157

Code Information:

Product Codes ASK-45552-RWJ3 CDC-35541-HPK1A EU-00750-45 PL-00750 AU-00420-MAJO CDC-35541-VPS EU-02041-ML PL-00755 CDC-34041-HPK1A CDC-35552-HPK1A EU-24041-HPMSB PR-35552-HPHNM CDC-34041-VPS CDC-35552-VPS EU-24052-HPMSB PR-45563-HPHNM CDC-34052-HPK1A CDC-41563-JX1A EU-25041-HPMSB UK-00420-MID CDC-34052-VPS CDC-44041-HPK1A EU-25052-HPMSB UK-00420-RCHT CDC-35041-HPK1A CDC-44052-HPK1A EU-25063-HPMSB UK-00420-THT CDC-35041-VPS CDC-44063-HPK1A EU-25541-HPMSB UK-04041-RDEH CDC-35052-HPK1A CDC-45063-HPK1A EU-25552-HPMSB UK-05041-MSB CDC-35052-VPS CDC-45563-HPK1A IB-01652 UK-05041-RDEH CDC-35063-HPK1A EU-00740-45 PL-00740 UK-05052-RCHT

Distribution Pattern:

World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated