Reported Nov 11, 2015 · Terminated

ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC…

Arrow International Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607

Is this the product you have?

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.

Lot codes and dates: 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
Amount recalled: 12,157

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Medical device recalls

Other recalls from Arrow International Inc.

72 in total.

Where it was distributed

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