Recall Z-0537-2012 ยท KDT Container, Specimen Mailer And Storage, Sterile
Heritage Labs International LLC
The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother Blood Kit, Product A2010, Kit #BA0057371, and Training Kit, A2010T, Kit #TA0000151, each kit packed in a bag or envelope, 25 kits/shipping carton, and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies. Blood specimen collection
| Date | Jan 11, 2012 (initiated Jan 9, 2011) |
| Status | Terminated |
| Reason | Kits contain recalled Triad alcohol pads |
| Root cause | Material/Component Contamination |
| Action | 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 ques |
| Quantity | A2010 - 550 kits; A2010T - 125 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.