Recall Z-1131-2013 ยท KST System, Blood Collection, Vacuum-Assisted, Manual
Heritage Labs International LLC
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,
| Date | Apr 18, 2013 (initiated Feb 6, 2013) |
| Status | Terminated |
| Reason | The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results. |
| Root cause | Material/Component Contamination |
| Action | The recalling firm contacted 25 of their 26 customers by phone on February 5, 2013, to notify them of the recall and sent a follow up memo on February 6, 2013, During the call, the firm reminded their customers how many recalled kits they recieved and instructed them to go through the kits and pull the recalled lots. The recalled kits are to be returned to the recalling firm and the firm sent a follow-up memo on February 6, 2013, with the shipping label their customers to place on the returning kit shipping box. This memo was sent to the customers by overnight Fed-ex mail and the ship l |
| Quantity | 25 kits |
| Distribution | Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.