FDA-Device2013-04-24Class II
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.
Heritage Labs International LLC
Hazard
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Sold states
Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
Affected count
25 kits
Manufactured in
560 N Rogers Rd, N/A, Olathe, KS, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2013Don't want to check this manually?
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