Device recall
Z-2130-2020: Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex…
FDA device recall · Class II · TELEFLEX MEDICAL INC
Key facts
| Recall number (Z-number) | Z-2130-2020 |
|---|---|
| Recall event | 85551 |
| Product | Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture… |
| Product code | BSP |
| Recalling firm | TELEFLEX MEDICAL INC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K911260 |
| FEI number | 3005747797 |
At a glance
- 1–9 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