FDAFDA · Food and drugs·Recall number Z-1131-2013
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.
Published April 24, 2013 · Recall initiated: February 6, 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
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heritage Labs International LLC
- Distributor
- Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
- Lot
- Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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