Recall Z-0531-2012
Heritage Labs International LLC · initiated January 9, 2011
Product
Heritage Labs Wellness Kits, Product A1769, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
Codes / lots: All kits containing Triad alcohol prep pads
Reason for recall
Kits contain recalled Triad alcohol pads
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-0531-2012
- Initiated
- January 9, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- December 26, 2012
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 153,300 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and Germany
- Recalling firm
- Heritage Labs International LLC, Olathe, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0524-2012 | Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0525-2012 | Heritage Labs DBS/Urine Collection Kit, Product A1101, packed in bags in bulk, 25…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0526-2012 | Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0527-2012 | Benicomp Supplies Kit, Product A1740. Each kit contains 1 Triad Medium Alcohol Prep Pad…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0528-2012 | Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0529-2012 | Heritage Labs Wellness Kits w/Purple Top, Product A1767, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0530-2012 | Heritage Labs Wellness Kits, Product A1768, each kit packed in a bag or envelope in…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0532-2012 | Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope.…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0533-2012 | H & W Research Kit, Product A1776, each kit packed in a bag or envelope. 25…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0534-2012 | Rules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0535-2012 | Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0536-2012 | The National Children's Study Adult Blood P1 Mother Kit, Product A2000, Kit #BB5649523…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0537-2012 | The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0538-2012 | The National Children's Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0539-2012 | The National Children's Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0540-2012 | The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0541-2012 | The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0542-2012 | AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0543-2012 | AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352, each…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0544-2012 | The National Children's Study Adult Blood Birth Mother Kit/Heritage Labs Westat Birth…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0545-2012 | The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0546-2012 | Heritage Labs Yale Research Kit, Product A2364, 50 kits/shipping carton, each kit packed…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0547-2012 | Appraise DBS Kit, Product K4002, each kit packed in a bag or envelope and contains 1…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0548-2012 | Nationwide DBS Collection Kit, Product K4003, each kit packed in a bag or envelope and…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0549-2012 | Medical Mutual Blood Collection Kit, Product K6500, each kit packed in a bag or envelope…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0550-2012 | Alere Blood Collection Kit (Consumer Life Insurance), Product K6700, each kit packed in…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0551-2012 | Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0552-2012 | Appraise A1C Test Pak Kit (Medical Mutual of Ohio), Product K7000, each kit packed in a…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0553-2012 | Appraise A1C (Retail) Collection Kit, Product K7050, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |
| Z-0554-2012 | Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit…Kits contain recalled Triad alcohol pads | 01/09/2011Terminated |