H & W Principal DBS Collection Kit, Product K8305, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection
FDA Recall Z-0574-2012 · Posted 2012-01-11
Recalling FirmHeritage Labs International LLC
Recall StatusTerminated
Product CodeLCP
Date Initiated2011-01-09
Date Terminated2012-12-26
Product Quantity3,278 kits
Reason for Recall
Kits contain recalled Triad alcohol pads
Firm 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 questions call (888)764-4120.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.