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Terminated

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

FDA Recall Z-0542-2012 · Posted 2012-01-11

Recalling FirmHeritage Labs International LLC
Recall StatusTerminated
Product CodeJKA
Date Initiated2011-01-09
Date Terminated2012-12-26
Product Quantity900 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.

K993787APPRAISE-CARDIO SAMPLE COLLECTION KITOsborn Group, Inc. · 2000-04-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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