Drug recall
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20…
FDA recall event 82289 · Class II · Medical Action Industries Inc
Key facts
| Event ID | 82289 |
|---|---|
| Recall numbers | Z-1068-2019 |
| Recalling firm | Medical Action Industries Inc |
| Product type | Devices |
| Products | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential lack of sterility assurance |
| Initiation date | Mar 1, 2019 |
| Report date | Apr 3, 2019 |
| Termination date | Apr 6, 2021 |
| City | Arden |
| State | NC |
| Country | United States |
| FEI number | 1030451 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: