FDAFDA · Food and drugs·Recall number Z-1965-2013
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Published August 21, 2013 · Recall initiated: July 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
- Lot
- Catalog # AK-17702-CDC, lot # RF2083258
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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