The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product A2362, each kit packed in a bag or envelope and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. NOTE: The master carton that went to the customer was misidentified as the Westat Child BNS Saliva Kit but actually contained the Child Hair Kit. Blood specimen collection
Recall
- Recall Number
- Z-0545-2012
- Event Number
- 57863
- Firm
- Heritage Labs International LLC
- FEI Number
- 1000118383
- Product Code
- KDT
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- January 9, 2011
- Posted
- January 11, 2012
- Terminated
- December 26, 2012
- Address
- 560 N Rogers Rd, Olathe, KS, 66062-1211
Description
The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product A2362, each kit packed in a bag or envelope and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. NOTE: The master carton that went to the customer was misidentified as the Westat Child BNS Saliva Kit but actually contained the Child Hair Kit. Blood specimen collection
Kits contain recalled Triad alcohol pads
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.
Worldwide Distribution - USA (nationwide) and Germany
50 kits