Device recall
Z-0925-2023: Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock…
FDA device recall · Class II · International Medical Industries, Inc.
Key facts
| Recall number (Z-number) | Z-0925-2023 |
|---|---|
| Recall event | 91276 |
| Product | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number… |
| Product code | LHI |
| Recalling firm | International Medical Industries, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K173577 |
| FEI number | 1217831 |
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