Device recall
Z-0542-2012: AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine…
FDA device recall · Class II · Heritage Labs International LLC
Key facts
| Recall number (Z-number) | Z-0542-2012 |
|---|---|
| Recall event | 57863 |
| Product | 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… |
| Product code | JKA |
| Recalling firm | Heritage Labs International LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 26, 2012 |
| 510(k) numbers | K993787 |
| FEI number | 1000118383 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database