Device recall
Z-0355-2016: U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold…
FDA device recall · Class II · Procedure Products, Inc.
Key facts
| Recall number (Z-number) | Z-0355-2016 |
|---|---|
| Recall event | 72596 |
| Product | U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula… |
| Product code | DRE |
| Recalling firm | Procedure Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2016 |
| 510(k) numbers | K810859 |
| FEI number | 3020778 |
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