Device product
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.
Z-1131-2013
Product summary
- Event
- Event 64848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 kits
- Official record key
device-enforcement:Z-1131-2013
Official wording
Reason: The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Code information: Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013
Distribution pattern: Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
Derived failure modes
-
Unknown
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.