Z-1131-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- February 6, 2013
- Termination Date
- November 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 kits
Product Description
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.
Reason for Recall
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Distribution Pattern
Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
Code Information
Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013