Device recall
Z-0784-2013: THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The…
FDA device recall · Class II · Lansinoh Laboratories Inc
Key facts
| Recall number (Z-number) | Z-0784-2013 |
|---|---|
| Recall event | 63390 |
| Product | THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a… |
| Product code | IME |
| Recalling firm | Lansinoh Laboratories Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2013 |
| FEI number | 3022898 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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