Recall Z-1131-2013— Heritage Labs International LLC
Class II · Terminated
Class II FDA medical device recall by Heritage Labs International LLC, initiated 2013-02-06, terminated 2013-11-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results..
- Recalling firm
- Heritage Labs International LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-06
- Terminated
- 2013-11-25
- Firm location
- Olathe, KS, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.