Device recall
Z-0193-2016: Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices…
FDA device recall · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Recall number (Z-number) | Z-0193-2016 |
|---|---|
| Recall event | 72274 |
| Product | Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira… |
| Product code | FMF |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2016 |
| 510(k) numbers | K960248 |
| FEI number | 1000138491 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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