Device recall
Z-1828-2013: Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec…
FDA device recall · Class II · Steritec Products Mfc. Co., Inc.
Key facts
| Recall number (Z-number) | Z-1828-2013 |
|---|---|
| Recall event | 65473 |
| Product | Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization… |
| Product code | JOJ |
| Recalling firm | Steritec Products Mfc. Co., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2013 |
| 510(k) numbers | K001444 |
| FEI number | 1000125215 |
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