Recall Z-0542-2012 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Heritage Labs International LLC
AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and subassembly collection packs (vacuum bag, spirometry bag, ambient kit inside pouch, blood tube "cold pouch", needle kit). 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 | 900 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993787 | APPRAISE-CARDIO SAMPLE COLLECTION KIT Osborn Group, Inc., Apr 14, 2000 |