Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope. (This kit has since changed to pro
FDA device recall Z-0532-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Heritage Labs International LLC
- Reason for recall
- Kits contain recalled Triad alcohol pads
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 3,231 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and Germany
- Date initiated
- 2011-01-09
- Date posted
- 2012-01-11
- Date terminated
- 2012-12-26
- Location
- Olathe, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCHEK-A1C SAMPLE COLLECTION KIT (K990899) | Osborn Group, Inc. | 1999-12-21 |